Instrument Surgical Guide Suppliers
Limit companies to: Worldwide USA
Conmed Integrated Systems | Address: 1815 NW 169th Place, Suite 4020, Beaverton, Oregon 97006, USA 
www.conmed.com/IntegratedSystems_newdesign.php | Send Inquiry | Phone: +1-(503)-614-1106
Products: Cables, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Tubing, Integrated OR Systems, Catheters, ...
Conmed Integrated Systems provides technology and service for the medical environment. We design completely integrated surgical suites and other patient critical care environments. We offer products l more...
www.conmed.com/IntegratedSystems_newdesign.php | Send Inquiry | Phone: +1-(503)-614-1106
Products: Cables, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Tubing, Integrated OR Systems, Catheters, ...
Conmed Integrated Systems provides technology and service for the medical environment. We design completely integrated surgical suites and other patient critical care environments. We offer products l more...
Aesculap Inc. | Address: 3773 Corporate Parkway, Center Valley, Pennsylvania 18034, USA
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Vaginal Retractors (FDA Code: HDL), Curettes, Drills, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Vaginal Retractors (FDA Code: HDL), Curettes, Drills, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
Small Bone Innovations, Inc | Address: 1380 S. Pennsylvania Avenue, Morrisville, Pennsylvania 19067, USA
www.totalsmallbone.com | Phone: +1-(215)-428-1791
Products: Forceps (FDA Code: HTD), Radial Head Implants, MP and PIP Joint Implants, CMC and IP Joint Implants, Total Wrist Arthroplasty, Bone Rasps (FDA Code: HTR), ...
Small Bone Innovations, Inc. delivers arthroplasty, fixation, trauma and biologic solutions. Our Head™ proximal radial head is designed to anatomically articulate with the convexity of the capit more...
www.totalsmallbone.com | Phone: +1-(215)-428-1791
Products: Forceps (FDA Code: HTD), Radial Head Implants, MP and PIP Joint Implants, CMC and IP Joint Implants, Total Wrist Arthroplasty, Bone Rasps (FDA Code: HTR), ...
Small Bone Innovations, Inc. delivers arthroplasty, fixation, trauma and biologic solutions. Our Head™ proximal radial head is designed to anatomically articulate with the convexity of the capit more...
Wright Medical Technology, Inc. | Address: 5677 Airline Road, Arlington, Tennessee 38002, USA
www.wmt.com | Send Inquiry | Phone: +1-(901)-867-9971, 800-238-7117
FDA Registration: 3012429289 Year Established: 1950 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO 9002, ISO 9003, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Tibial Inserts, Patellar Implants, Metal and Ceramic Liners, ...
Wright Medical Technology, Inc. is a global orthopaedic medical device company. Our Advance® Uni-Knee renders normal motion and leads to a longer implant life that delays or prevents the need for more...
www.wmt.com | Send Inquiry | Phone: +1-(901)-867-9971, 800-238-7117
FDA Registration: 3012429289 Year Established: 1950 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO 9002, ISO 9003, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Tibial Inserts, Patellar Implants, Metal and Ceramic Liners, ...
Wright Medical Technology, Inc. is a global orthopaedic medical device company. Our Advance® Uni-Knee renders normal motion and leads to a longer implant life that delays or prevents the need for more...
Smith & Nephew Inc. | Address: 1450 Brooks Road, Memphis, Tennessee 38116, USA
www.smith-nephew.com | Phone: +1-(901)-399-2121, 800-821-5700
Annual Revenues: USD 50-100 Million Employee Count: ~400 Quality: ISO 9001 Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Fixation Forceps, Tissue Forceps, Kremer Fixation Forceps, Double Prong Skin Hooks, ...
Smith & Nephew is a wound care management company that manufactures and supplies medical products for the diagnosis of wound care management. Our products & services for wound, skin, IV, & burn care i more...
www.smith-nephew.com | Phone: +1-(901)-399-2121, 800-821-5700
Annual Revenues: USD 50-100 Million Employee Count: ~400 Quality: ISO 9001 Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Fixation Forceps, Tissue Forceps, Kremer Fixation Forceps, Double Prong Skin Hooks, ...
Smith & Nephew is a wound care management company that manufactures and supplies medical products for the diagnosis of wound care management. Our products & services for wound, skin, IV, & burn care i more...
Orthofix Inc. | Address: 1720 Bray Central Drive, McKinney, Texas 75069, USA
www.orthofix.com | Send Inquiry | Phone: +1-(469)-742-2500, 800-535-4492
FDA Registration: 2183449 Year Established: 1980 Employee Count: ~200 Quality: ISO Certified
Products: Probes (FDA Code: HXB), Femoral IM Nails, Ankle External Fixators, Elbow External Fixators, Hand External Fixators, Static External Fixators, ...
Orthofix Inc. designs, manufactures & distributes medical equipment, mainly for the orthopedic market. Our orthopedics, spine and sports medicine divisions offer innovative treatment options for adult more...
www.orthofix.com | Send Inquiry | Phone: +1-(469)-742-2500, 800-535-4492
FDA Registration: 2183449 Year Established: 1980 Employee Count: ~200 Quality: ISO Certified
Products: Probes (FDA Code: HXB), Femoral IM Nails, Ankle External Fixators, Elbow External Fixators, Hand External Fixators, Static External Fixators, ...
Orthofix Inc. designs, manufactures & distributes medical equipment, mainly for the orthopedic market. Our orthopedics, spine and sports medicine divisions offer innovative treatment options for adult more...
Boss Instruments, Ltd. | Address: 395 Reas Ford Road, Suite 120, Earlysville, Virginia 22936, USA
www.bossinst.com | Send Inquiry | Phone: +1-(800)-210-2677
FDA Registration: 1056350 Year Established: 1990 Annual Revenues: < USD 1 Million Employee Count: ~10 Quality: ISO 9000, ISO 9002, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Retractors, Saws (FDA Code: HSO), Tissue Forceps, ...
Boss Instruments, Ltd. is a surgical instrument company which concentrates on the manufacture and continual development of specialty lines of instruments include ear, nose, and throat, general surgery more...
www.bossinst.com | Send Inquiry | Phone: +1-(800)-210-2677
FDA Registration: 1056350 Year Established: 1990 Annual Revenues: < USD 1 Million Employee Count: ~10 Quality: ISO 9000, ISO 9002, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Retractors, Saws (FDA Code: HSO), Tissue Forceps, ...
Boss Instruments, Ltd. is a surgical instrument company which concentrates on the manufacture and continual development of specialty lines of instruments include ear, nose, and throat, general surgery more...
Ad-Tech Medical Instrument Corporation | Address: 1901 William Street, Racine, Wisconsin 53404, USA
www.adtechmedical.com | Send Inquiry | Phone: +1-(262)-634-1555
FDA Registration: 2183456 Year Established: 1983 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Electrocorticography, Intracranial Electrodes, Special Application Electrodes, Subpial Transectors, Brain Biopsy Needles, Brain Biopsy Needle Guides, ...
Ad-Tech Medical Instrument Corporation provides the finest devices for the surgical treatment of epilepsy, as well as devices for neurosurgery. We are an ISO 13485: 2003 certified company. We offer pr more...
www.adtechmedical.com | Send Inquiry | Phone: +1-(262)-634-1555
FDA Registration: 2183456 Year Established: 1983 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Electrocorticography, Intracranial Electrodes, Special Application Electrodes, Subpial Transectors, Brain Biopsy Needles, Brain Biopsy Needle Guides, ...
Ad-Tech Medical Instrument Corporation provides the finest devices for the surgical treatment of epilepsy, as well as devices for neurosurgery. We are an ISO 13485: 2003 certified company. We offer pr more...
EBI Patient Care, Inc. | Address: 1 Electro-biology Blvd., Guaynabo 00657, USA
Phone: +1-(973)-299-9300
FDA Registration: 3003435252
Products: Probes (FDA Code: HXB), Arthroscopes (FDA Code: HRX), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Bone Mallets (FDA Code: HXL), Human Bone Rasps (FDA Code: HTR), ...
EBI Patient Care, Inc. provides braces thermal therapy devices, spinal endoscopic system and cast bandage. more...
Phone: +1-(973)-299-9300
FDA Registration: 3003435252
Products: Probes (FDA Code: HXB), Arthroscopes (FDA Code: HRX), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Bone Mallets (FDA Code: HXL), Human Bone Rasps (FDA Code: HTR), ...
EBI Patient Care, Inc. provides braces thermal therapy devices, spinal endoscopic system and cast bandage. more...
Crystal Medical Technology | Address: 153 Cahaba Valley Parkway, Pelham, Alabama 35124, USA
www.crystalmedicaltech.com | Send Inquiry | Phone: +1-(205)-733-0901
FDA Registration: 1065595 Year Established: 1994 Annual Revenues: < USD 1 Million
Products: Drill Bit (FDA Code: HTW), Dental Implants, Tamps (FDA Code: HXG), Orthopedic Implant Devices, Surgical Instrument Tray (FDA Code: FSM), Instrument Surgical Guide (FDA Code: FZX), ...
Crystal Medical Technology manufactures dental implant systems and offers manufacturing & design solutions to all areas of orthopedic, dental implants & surgical related armamentarium. Our product is more...
www.crystalmedicaltech.com | Send Inquiry | Phone: +1-(205)-733-0901
FDA Registration: 1065595 Year Established: 1994 Annual Revenues: < USD 1 Million
Products: Drill Bit (FDA Code: HTW), Dental Implants, Tamps (FDA Code: HXG), Orthopedic Implant Devices, Surgical Instrument Tray (FDA Code: FSM), Instrument Surgical Guide (FDA Code: FZX), ...
Crystal Medical Technology manufactures dental implant systems and offers manufacturing & design solutions to all areas of orthopedic, dental implants & surgical related armamentarium. Our product is more...
Joimax, Inc. | Address: 275 E. Hacienda Avenue, Campbell, California 95008, USA
www.joimaxusa.com | Send Inquiry | Phone: +1-(408)-370-3005
FDA Registration: 3005042595
Products: Light Sources, Punches, Arthroscopes (FDA Code: HRX), Wire Twisters (FDA Code: HXS), Pulmonic Stenosis Clamps, Electrosurgical Systems, ...
Joimax, Inc. deals with endoscopic spinal surgery. We offer Tessys®, video twister™, C-camsource®, jIFP 2000™, Surgimax™ and JFM 1910™. Our Tessys® spinal stenosis more...
www.joimaxusa.com | Send Inquiry | Phone: +1-(408)-370-3005
FDA Registration: 3005042595
Products: Light Sources, Punches, Arthroscopes (FDA Code: HRX), Wire Twisters (FDA Code: HXS), Pulmonic Stenosis Clamps, Electrosurgical Systems, ...
Joimax, Inc. deals with endoscopic spinal surgery. We offer Tessys®, video twister™, C-camsource®, jIFP 2000™, Surgimax™ and JFM 1910™. Our Tessys® spinal stenosis more...
Zimmer Dental, Inc. | Address: 1900 Aston Ave., Carlsbad, California 92008, USA
www.zimmerdental.com | Phone: +1-(760)-929-4300, 800-854-7019
FDA Registration: 2023141 Year Established: 1927 Annual Revenues: USD 100-500 Million Employee Count: ~410 Quality: ISO 13485, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Arthroscopes (FDA Code: HRX), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), ...
Zimmer Dental, Inc. specializes in dental implant products. Our product portfolio comprises of root-form endosseous dental implants, prosthetic attachments for restoration, surgical instrumentation, c more...
www.zimmerdental.com | Phone: +1-(760)-929-4300, 800-854-7019
FDA Registration: 2023141 Year Established: 1927 Annual Revenues: USD 100-500 Million Employee Count: ~410 Quality: ISO 13485, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Arthroscopes (FDA Code: HRX), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), ...
Zimmer Dental, Inc. specializes in dental implant products. Our product portfolio comprises of root-form endosseous dental implants, prosthetic attachments for restoration, surgical instrumentation, c more...
Synvasive Technology, Inc. | Address: 4925 Robert J. Mathews Parkway, El Dorado Hills, California 95762, USA
www.synvasive.com | Send Inquiry | Phone: +1-(916)-939-3913, 800-925-2337
FDA Registration: 2950261
Products: Orthopaedic Instruments, General & Plastic Saw Surgical Blade (FDA Code: GFA), Instrument Surgical Guide (FDA Code: FZX), Ligament Drill Guide (FDA Code: LXI), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Orthopedic Surgical Table and Accessories (FDA Code: JEB), ...
Synvasive Technology, Inc. specializes in providing operative solutions to enhance reconstructive surgery. We develop, manufacture and distribute patented & proprietary instruments enhancing reconstru more...
www.synvasive.com | Send Inquiry | Phone: +1-(916)-939-3913, 800-925-2337
FDA Registration: 2950261
Products: Orthopaedic Instruments, General & Plastic Saw Surgical Blade (FDA Code: GFA), Instrument Surgical Guide (FDA Code: FZX), Ligament Drill Guide (FDA Code: LXI), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Orthopedic Surgical Table and Accessories (FDA Code: JEB), ...
Synvasive Technology, Inc. specializes in providing operative solutions to enhance reconstructive surgery. We develop, manufacture and distribute patented & proprietary instruments enhancing reconstru more...
Innovative Med Inc. | Address: 4 Autry, Suite B, Irvine, California 92618, USA
www.imibeauty.com | Send Inquiry | Phone: +1-(949)-458-1897, 877-779-9492
FDA Registration: 3004112621 Year Established: 1999 Annual Revenues: USD 1-5 Million Quality: ISO Certified
Products: Dissectors, Eye Shields, Eyeshields, Catheter Accessories (FDA Code: KGZ), Instruments surgical, Medical Eye shield, ...
Innovative Med Inc. specializes in aesthetic surgery products and skin care products. Our product categories are aspiration, breast instruments, cannulas, dissectors, diamond wires, and syringe locks. more...
www.imibeauty.com | Send Inquiry | Phone: +1-(949)-458-1897, 877-779-9492
FDA Registration: 3004112621 Year Established: 1999 Annual Revenues: USD 1-5 Million Quality: ISO Certified
Products: Dissectors, Eye Shields, Eyeshields, Catheter Accessories (FDA Code: KGZ), Instruments surgical, Medical Eye shield, ...
Innovative Med Inc. specializes in aesthetic surgery products and skin care products. Our product categories are aspiration, breast instruments, cannulas, dissectors, diamond wires, and syringe locks. more...
Interventional Spine, Inc. | Address: 13700 Alton Pkwy., Suite 160, Irvine, California 92618, USA
www.i-spineinc.com | Send Inquiry | Phone: +1-(949)-472-0006, 800-497-0484
Year Established: 2000
Products: Surgical Retractor Systems (FDA Code: GAD), Drill Bit (FDA Code: HTW), Bone Taps (FDA Code: HWX), Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Tissue Retractors, ...
Interventional Spine, Inc. focuses on the design, development and marketing of patented percutaneous systems to treat lower back pain. Our products are intended to bridge the therapeutic continuum of more...
www.i-spineinc.com | Send Inquiry | Phone: +1-(949)-472-0006, 800-497-0484
Year Established: 2000
Products: Surgical Retractor Systems (FDA Code: GAD), Drill Bit (FDA Code: HTW), Bone Taps (FDA Code: HWX), Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Tissue Retractors, ...
Interventional Spine, Inc. focuses on the design, development and marketing of patented percutaneous systems to treat lower back pain. Our products are intended to bridge the therapeutic continuum of more...
Medmetric Corp | Address: 7542 Trade St, San Diego, California 92121-2412, USA
www.medmetric.com | Send Inquiry | Phone: +1-(858)-536-9122
Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: CE Certified
Products: Assessment Equipment, Leg Holder, Instrument Surgical Guide (FDA Code: FZX), Table Operating Room Accessories (FDA Code: FWZ), Arthrometer (FDA Code: LYH), Non-Powered Dynamometer (FDA Code: HRW), ...
Medmetric Corp designs and manufactures sports medicine products for clinical, surgical and rehabilitation applications. We create medical and biomechanical principles. more...
www.medmetric.com | Send Inquiry | Phone: +1-(858)-536-9122
Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: CE Certified
Products: Assessment Equipment, Leg Holder, Instrument Surgical Guide (FDA Code: FZX), Table Operating Room Accessories (FDA Code: FWZ), Arthrometer (FDA Code: LYH), Non-Powered Dynamometer (FDA Code: HRW), ...
Medmetric Corp designs and manufactures sports medicine products for clinical, surgical and rehabilitation applications. We create medical and biomechanical principles. more...
Spinevision, Inc. | Address: 301 Howard St., Suite 970, San Francisco, California 94105, USA
www.spinevision.net | Phone: +1-(415)-5128001
FDA Registration: 1067145
Products: Probes (FDA Code: HXB), Surgical Retractor Systems (FDA Code: GAD), Cervical Spine Retractor System, Hand Held Instruments, Drill Bit (FDA Code: HTW), Bone Taps (FDA Code: HWX), Small Depth Gauge (FDA Code: HTJ), ...
Spinevision, Inc.provides spinal treatment products. We offer PLUS®, X-PLUS™, UNI-Thread®, Spacevision® and C3® products. UNI-Thread® versatile thoraco-lumbar spinal system h more...
www.spinevision.net | Phone: +1-(415)-5128001
FDA Registration: 1067145
Products: Probes (FDA Code: HXB), Surgical Retractor Systems (FDA Code: GAD), Cervical Spine Retractor System, Hand Held Instruments, Drill Bit (FDA Code: HTW), Bone Taps (FDA Code: HWX), Small Depth Gauge (FDA Code: HTJ), ...
Spinevision, Inc.provides spinal treatment products. We offer PLUS®, X-PLUS™, UNI-Thread®, Spacevision® and C3® products. UNI-Thread® versatile thoraco-lumbar spinal system h more...
Medtronic Spine LLC | Address: 1221 Crossman Ave., Sunnyvale, California 94089, USA
www.medtronicspine.com | Send Inquiry | Phone: +1-(408)-548-6500, 877-690-5353
FDA Registration: 2953769 Year Established: 1994
Products: Forceps (FDA Code: HTD), Drill Bit (FDA Code: HTW), Tamps (FDA Code: HXG), Drill Bits & Bone Taps, Cannulated Drill Bit, Anesthetic Conduction Needle with/without Introducer (FDA Code: BSP), ...
Medtronic Spine LLC offers online resource for neck pain, back pain, spinal health and treatment options for the same. Our cervical products for spinal surgery include plates, tissues and interbodies more...
www.medtronicspine.com | Send Inquiry | Phone: +1-(408)-548-6500, 877-690-5353
FDA Registration: 2953769 Year Established: 1994
Products: Forceps (FDA Code: HTD), Drill Bit (FDA Code: HTW), Tamps (FDA Code: HXG), Drill Bits & Bone Taps, Cannulated Drill Bit, Anesthetic Conduction Needle with/without Introducer (FDA Code: BSP), ...
Medtronic Spine LLC offers online resource for neck pain, back pain, spinal health and treatment options for the same. Our cervical products for spinal surgery include plates, tissues and interbodies more...
Seaspine | Address: 2302 La Mirada Drive, Vista, California 92081-7862, USA
www.seaspine.com | Send Inquiry | Phone: +1-(760)-727-8399
Year Established: 2002 Annual Revenues: USD 10-25 Million Employee Count: ~20
Products: Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Drill Bit (FDA Code: HTW), ...
Seaspine provides medical products for the spine fusion market. Our Cardiff™ anterior cervical plate system has a low profile design. This system has large windows for viewing the disc space and more...
www.seaspine.com | Send Inquiry | Phone: +1-(760)-727-8399
Year Established: 2002 Annual Revenues: USD 10-25 Million Employee Count: ~20
Products: Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Drill Bit (FDA Code: HTW), ...
Seaspine provides medical products for the spine fusion market. Our Cardiff™ anterior cervical plate system has a low profile design. This system has large windows for viewing the disc space and more...
Acme-Monaco Corp. | Address: 75 Winchell Drive, New Britain, Connecticut 06052-1017, USA
www.acmemonaco.com | Send Inquiry | Phone: +1-(860)-224-1349
FDA Registration: 1293141 Year Established: 1947 Annual Revenues: USD 10-25 Million Employee Count: ~150 Quality: ISO 9001, CE Certified
Products: Catheter Stylets (FDA Code: DRB), Guidewire Catheter (FDA Code: DQX), Angioplasty Guidewire, Instrument Surgical Guide (FDA Code: FZX), Contract Manufacturing, Angiographic Wire Guide, ...
Acme-Monaco Corp. is a manufacturer of custom spring products. Our product line includes springs, wire forms, stampings, non-sterile medical assemblies, such as surgical staples, guide wires, and styl more...
www.acmemonaco.com | Send Inquiry | Phone: +1-(860)-224-1349
FDA Registration: 1293141 Year Established: 1947 Annual Revenues: USD 10-25 Million Employee Count: ~150 Quality: ISO 9001, CE Certified
Products: Catheter Stylets (FDA Code: DRB), Guidewire Catheter (FDA Code: DQX), Angioplasty Guidewire, Instrument Surgical Guide (FDA Code: FZX), Contract Manufacturing, Angiographic Wire Guide, ...
Acme-Monaco Corp. is a manufacturer of custom spring products. Our product line includes springs, wire forms, stampings, non-sterile medical assemblies, such as surgical staples, guide wires, and styl more...
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FDA Code / Regulation: FZX / 878.4800
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9.
