Wire Cutters Suppliers
Limit companies to: Worldwide USA
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...
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...
Koros Usa, Inc. | Address: 610 Flinn Ave., Moorpark, California 93021, USA
www.korosusa.com | Send Inquiry | Phone: +1-(805)-529-0825
FDA Registration: 2023918
Products: Probes (FDA Code: HXB), Retractors, Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Wire Twisters (FDA Code: HXS), Cervical Retractor System, ...
Koros Usa, Inc. is a supplier of surgical instruments. Our product line includes cardio & thoracic, neuro and orthopedic instruments, pro retractor sets, V-Track retractor sets & XL instruments. Our c more...
www.korosusa.com | Send Inquiry | Phone: +1-(805)-529-0825
FDA Registration: 2023918
Products: Probes (FDA Code: HXB), Retractors, Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Wire Twisters (FDA Code: HXS), Cervical Retractor System, ...
Koros Usa, Inc. is a supplier of surgical instruments. Our product line includes cardio & thoracic, neuro and orthopedic instruments, pro retractor sets, V-Track retractor sets & XL instruments. Our c 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...
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...
Lancer Orthodontics, Inc. | Address: 2330 Cousteau Court, Vista, California 92081, USA
www.lancerortho.com | Send Inquiry | Phone: +1-(760)-744.5585
FDA Registration: 2020397
Products: Self-Retaining Retractors (FDA Code: FFO), Wire Cutters (FDA Code: HXZ), Templates (FDA Code: HWT), ...
Lancer Orthodontics, Inc. specializes in offering products for orthodontic industry. Our products include brackets, bands, and buccal tubes. We also supply wires, instruments, elastics, bonding materi more...
www.lancerortho.com | Send Inquiry | Phone: +1-(760)-744.5585
FDA Registration: 2020397
Products: Self-Retaining Retractors (FDA Code: FFO), Wire Cutters (FDA Code: HXZ), Templates (FDA Code: HWT), ...
Lancer Orthodontics, Inc. specializes in offering products for orthodontic industry. Our products include brackets, bands, and buccal tubes. We also supply wires, instruments, elastics, bonding materi more...
Biomet Microfixation | Address: 1520 Tradeport Dr., Jacksonville, Florida 32218-2480, USA
www.biometmicrofixation.com | Send Inquiry | Phone: +1-(904)-741-4400, 800-874-7711
FDA Registration: 1032347 Year Established: 1965
Products: Forceps (FDA Code: HTD), Demineralized Bone Matrix, Lacrimal Probes (FDA Code: HNL), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Orbital Retractors, ...
Biomet Microfixation manufactures a complete range of craniomaxillofacial products. We offer products for neurosurgical, plastic, oral & maxillofacial, craniofacial, pediatric, ENT and cardiothoracic more...
www.biometmicrofixation.com | Send Inquiry | Phone: +1-(904)-741-4400, 800-874-7711
FDA Registration: 1032347 Year Established: 1965
Products: Forceps (FDA Code: HTD), Demineralized Bone Matrix, Lacrimal Probes (FDA Code: HNL), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Orbital Retractors, ...
Biomet Microfixation manufactures a complete range of craniomaxillofacial products. We offer products for neurosurgical, plastic, oral & maxillofacial, craniofacial, pediatric, ENT and cardiothoracic more...
Hu-Friedy | Address: 3232 N.Rockwell, Chicago, Illinois 60618-5982, USA
www.hu-friedy.com | Send Inquiry | Phone: +001-(800)-483-7433
FDA Registration: 1416605 Year Established: 1908 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9002, CE Certified
Products: Curettes, Forceps (FDA Code: HTD), Retractors, Scissors, Gastroenterologic Needle Holder (FDA Code: FHQ), Wire Twisters (FDA Code: HXS), ...
Hu-Friedy offers a wide range of periodontal, restorative, diagnostic, surgery and orthodontic instruments. We specialize in manufacturing quality handheld dental instruments. We develop the next gene more...
www.hu-friedy.com | Send Inquiry | Phone: +001-(800)-483-7433
FDA Registration: 1416605 Year Established: 1908 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9002, CE Certified
Products: Curettes, Forceps (FDA Code: HTD), Retractors, Scissors, Gastroenterologic Needle Holder (FDA Code: FHQ), Wire Twisters (FDA Code: HXS), ...
Hu-Friedy offers a wide range of periodontal, restorative, diagnostic, surgery and orthodontic instruments. We specialize in manufacturing quality handheld dental instruments. We develop the next gene more...
Zoll Dental | Address: 7450 North Natchez Ave., Niles, Illinois 60714, USA
www.zolldental.com | Send Inquiry | Phone: +1-(847)-647-1819
FDA Registration: 1422507
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Scissors, Gastroenterologic Needle Holder (FDA Code: FHQ), Lacrimal Probes (FDA Code: HNL), Wire Twisters (FDA Code: HXS), ...
Zoll Dental manufactures dental hand instruments. We provide re-tipping and re-sharpening services. Our products include dressing pliers, mirror handles, perio/hygiene instruments, operative instrumen more...
www.zolldental.com | Send Inquiry | Phone: +1-(847)-647-1819
FDA Registration: 1422507
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Scissors, Gastroenterologic Needle Holder (FDA Code: FHQ), Lacrimal Probes (FDA Code: HNL), Wire Twisters (FDA Code: HXS), ...
Zoll Dental manufactures dental hand instruments. We provide re-tipping and re-sharpening services. Our products include dressing pliers, mirror handles, perio/hygiene instruments, operative instrumen more...
Bio-Bridge Science, Inc. | Address: 1211 West 22nd St., Suite 615, Oak Brook, Illinois 60523, USA
www.bbsinstruments.com | Send Inquiry | Phone: +1-(630)-9280869
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Bone Hooks (FDA Code: KIK), ...
Bio-Bridge Science, Inc. is a provider of surgical and dental instruments. Our surgical instruments include surgical clamps, forceps, scalpel handles, scissors, tweezers and retractors. Our dental ins more...
www.bbsinstruments.com | Send Inquiry | Phone: +1-(630)-9280869
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Bone Hooks (FDA Code: KIK), ...
Bio-Bridge Science, Inc. is a provider of surgical and dental instruments. Our surgical instruments include surgical clamps, forceps, scalpel handles, scissors, tweezers and retractors. Our dental ins more...
Instrumed International, Inc. | Address: 626 Cooper Court, Schaumburg, Illinois 60173, USA
www.instrumedinc.biz | Phone: +1-(847)-908-0292
FDA Registration: 1421101
Products: Laparoscopic Equipment, Vaginal Retractors (FDA Code: HDL), Micro Surgery Instruments, Bipolar Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), Retractor System, ...
Instrumed International, Inc. specializes in providing reusable surgical instruments. We offer surgical products for bipolar, CV/thoracic, ENT, general, hand & micro surgery, laparoscopic, laryngeal, more...
www.instrumedinc.biz | Phone: +1-(847)-908-0292
FDA Registration: 1421101
Products: Laparoscopic Equipment, Vaginal Retractors (FDA Code: HDL), Micro Surgery Instruments, Bipolar Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), Retractor System, ...
Instrumed International, Inc. specializes in providing reusable surgical instruments. We offer surgical products for bipolar, CV/thoracic, ENT, general, hand & micro surgery, laparoscopic, laryngeal, more...
Symmetry Medical USA, Inc. | Address: 486 West 350 North, Warsaw, Indiana 46582, USA
www.symmetrymedical.com/Products/Instruments/Default.aspx | Phone: +1-(574)-267-8700
FDA Registration: 1828464 Employee Count: ~1800
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Ophthalmology Forceps, Dissectors, Gastroenterologic Needle Holder (FDA Code: FHQ), Blade Holders, ...
Symmetry Medical USA, Inc. provides implants, instruments and cases to orthopedic device manufacturers. We also design, develop and produce products for companies in the arthroscopy, dental, laparosco more...
www.symmetrymedical.com/Products/Instruments/Default.aspx | Phone: +1-(574)-267-8700
FDA Registration: 1828464 Employee Count: ~1800
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Ophthalmology Forceps, Dissectors, Gastroenterologic Needle Holder (FDA Code: FHQ), Blade Holders, ...
Symmetry Medical USA, Inc. provides implants, instruments and cases to orthopedic device manufacturers. We also design, develop and produce products for companies in the arthroscopy, dental, laparosco more...
Tornier Inc. | Address: 100 Cummings Center, Suite 444c, Beverly, Massachusetts 01915, USA
www.tornier-us.com | Send Inquiry | Phone: +1-(978)-232-9997, 800-611-2992
FDA Registration: 3004983210
Products: Bone Rasps (FDA Code: HTR), Surgical Mesh (FDA Code: FTM), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Wire Cutters (FDA Code: HXZ), Surgical Instrument Tray (FDA Code: FSM), ...
Tornier Inc. specializes in orthopedic industry. We offer a broad range of joint replacement products including hips, knees, shoulders, ankles, and other extremity prostheses. We provide prosthesis de more...
www.tornier-us.com | Send Inquiry | Phone: +1-(978)-232-9997, 800-611-2992
FDA Registration: 3004983210
Products: Bone Rasps (FDA Code: HTR), Surgical Mesh (FDA Code: FTM), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Wire Cutters (FDA Code: HXZ), Surgical Instrument Tray (FDA Code: FSM), ...
Tornier Inc. specializes in orthopedic industry. We offer a broad range of joint replacement products including hips, knees, shoulders, ankles, and other extremity prostheses. We provide prosthesis de more...
Symmetry Medical Inc. | Address: New Bedford Industrial Park, New Bedford, Massachusetts 02745, USA
www.symmetrymedical.com | Phone: +1-(508)-998-4493
Products: Vaginal Retractors (FDA Code: HDL), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Instruments, Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), ...
Symmetry Medical Inc. manufactures implants, instruments and cases to orthopedic devices. We offer cases and trays that made of metal, plastic or hybrid. We provide forged, cast, machined and finished more...
www.symmetrymedical.com | Phone: +1-(508)-998-4493
Products: Vaginal Retractors (FDA Code: HDL), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Instruments, Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), ...
Symmetry Medical Inc. manufactures implants, instruments and cases to orthopedic devices. We offer cases and trays that made of metal, plastic or hybrid. We provide forged, cast, machined and finished more...
Key Surgical, Inc. | Address: 8101 Wallace Road, Suite 100, Eden Prairie, Minnesota 55344, USA
www.keysurgical.com | Send Inquiry | Phone: +1-(952)-914-9789, 800-541-7995
FDA Registration: 2183785 Year Established: 1988 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: ISO 9002, CE Certified
Products: Face Masks, Shoe Covers, Enzymatic Detergents, Face Mask Removers, Face Mask Treatments, Natural Face Masks, ...
Key Surgical, Inc. specilizes in medical products. We offer instrument prodtection, cleaning, personel protection, surgical instruments, wire and pin mangaements. instrument tracking, identification, more...
www.keysurgical.com | Send Inquiry | Phone: +1-(952)-914-9789, 800-541-7995
FDA Registration: 2183785 Year Established: 1988 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: ISO 9002, CE Certified
Products: Face Masks, Shoe Covers, Enzymatic Detergents, Face Mask Removers, Face Mask Treatments, Natural Face Masks, ...
Key Surgical, Inc. specilizes in medical products. We offer instrument prodtection, cleaning, personel protection, surgical instruments, wire and pin mangaements. instrument tracking, identification, more...
Phillips Environmental Products, Inc. | Address: 290 Arden Drive, Belgrade, Montana 59714, USA
www.thepett.com | Send Inquiry | Phone: +1-(406)-388-5999/877-520-0999
Products: Toilet Accessories, Commodes, Disposable Liners, Wire Cutters (FDA Code: HXZ), Bedpan (FDA Code: FOB), Sanitary Toilet Seat Cover, ...
Phillips Environmental Products, Inc. specializes in providing PETT®, which is dry toilet system. Our PETT® provides a sanitary method for transporting and disposing of both solid and liquid h more...
www.thepett.com | Send Inquiry | Phone: +1-(406)-388-5999/877-520-0999
Products: Toilet Accessories, Commodes, Disposable Liners, Wire Cutters (FDA Code: HXZ), Bedpan (FDA Code: FOB), Sanitary Toilet Seat Cover, ...
Phillips Environmental Products, Inc. specializes in providing PETT®, which is dry toilet system. Our PETT® provides a sanitary method for transporting and disposing of both solid and liquid h more...
Buxton Biomedical, Inc. | Address: 15a Melaine Lane, Unit 7, East Hanover, New Jersey 07936, USA
Phone: +1-(913)-560-4848
FDA Registration: 2248030
Products: Splints, Forceps (FDA Code: HTD), Mallets, Probes (FDA Code: HXB), Retractors, Saws (FDA Code: HSO), ...
Buxton Biomedical, Inc. specializes in providing mallets, self-retaining retractors, bone tampers, calipers, cannulae, dissectors, forceps, goniometers, needle holders, splints, strippers and wire cut more...
Phone: +1-(913)-560-4848
FDA Registration: 2248030
Products: Splints, Forceps (FDA Code: HTD), Mallets, Probes (FDA Code: HXB), Retractors, Saws (FDA Code: HSO), ...
Buxton Biomedical, Inc. specializes in providing mallets, self-retaining retractors, bone tampers, calipers, cannulae, dissectors, forceps, goniometers, needle holders, splints, strippers and wire cut more...
Westcon Orthopedics | Address: PO Box 337, Three Bridges, New Jersey 08887, USA
www.westconortho.com | Send Inquiry | Phone: +1-(908)-806-8981/ 800-382-4975
Year Established: 1989 Annual Revenues: < USD 1 Million
Products: Protective Surgical Cap, Compression Hosiery, Wire Cutters (FDA Code: HXZ), Radiation Protective Caps, Micro Wire Driver, Wire Driver, ...
Westcon Orthopedics specializes in manufacturing K-caps. Our K-cap is a protective capping for both intraoperative and external orthopedic wires. The caps are designed by orthopedic surgeons for patie more...
www.westconortho.com | Send Inquiry | Phone: +1-(908)-806-8981/ 800-382-4975
Year Established: 1989 Annual Revenues: < USD 1 Million
Products: Protective Surgical Cap, Compression Hosiery, Wire Cutters (FDA Code: HXZ), Radiation Protective Caps, Micro Wire Driver, Wire Driver, ...
Westcon Orthopedics specializes in manufacturing K-caps. Our K-cap is a protective capping for both intraoperative and external orthopedic wires. The caps are designed by orthopedic surgeons for patie more...
Greatbatch Medical, Inc., | Address: 10000 Wehrle Drive, Clarence, New York 14031, USA
www.greatbatchmedical.com | Send Inquiry | Phone: +1-(716)-759-5600
FDA Registration: 3004976965 Quality: ISO 13485 Certified
Products: Blades, Drills, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Catheter Introducers (FDA Code: DYB), Interference Screws, ...
Greatbatch medical is a designer and manufacturer of critical technologies that enhance the reliability and performance of medical devices and procedures. Our active stimulation components & assembly more...
www.greatbatchmedical.com | Send Inquiry | Phone: +1-(716)-759-5600
FDA Registration: 3004976965 Quality: ISO 13485 Certified
Products: Blades, Drills, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Catheter Introducers (FDA Code: DYB), Interference Screws, ...
Greatbatch medical is a designer and manufacturer of critical technologies that enhance the reliability and performance of medical devices and procedures. Our active stimulation components & assembly more...
Delta Surgical Instruments, Inc. | Address: 95 Schunnemunk Rd., Highland Mills, New York 10930, USA
www.deltasurgicalinstruments.com | Send Inquiry | Phone: +1-(845)-9283760
FDA Registration: 3005609209
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Bone Mallets (FDA Code: HXL), Human Bone Rasps (FDA Code: HTR), ...
Delta Surgical Instruments, Inc. manufactures dental surgical instruments. Our product line comprises of forceps, retractors, towel clamps, rasps, spinal punches, splinter forceps, sponge clamps, rong more...
www.deltasurgicalinstruments.com | Send Inquiry | Phone: +1-(845)-9283760
FDA Registration: 3005609209
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Bone Mallets (FDA Code: HXL), Human Bone Rasps (FDA Code: HTR), ...
Delta Surgical Instruments, Inc. manufactures dental surgical instruments. Our product line comprises of forceps, retractors, towel clamps, rasps, spinal punches, splinter forceps, sponge clamps, rong more...
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FDA Code / Regulation: HXZ / 888.4540
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
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 888.9.
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