100 mm Securing Post,2 Part Metal-Plastic Articulation Wrist Prosthesis Suppliers & Manufacturers

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100 mm Securing Post
Orthofix Inc.

2 Part Metal-Plastic Articulation Wrist Prosthesis (FDA Code: JWI / 888.38)

Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have either a one-part radial component made of alloys, such as cobalt-chromium-molybdenum, with an ultra-high molecular weight polyethylene bearing surface, or a two-part radial component made of alloys and an ultra-high molecular weight polyethylene ball that is mounted on the radial component with a trunnion bearing. The metallic portion of the two-part radial component is inserted into the radius. These devices have a metacarpal component(s) made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (888.3027).

Classification. Class II.

Biomet, Inc, Luxtec, Implants International Ltd.

3 Part Metal-Plastic-Metal Articulation Wrist Prosthesis (FDA Code: JWJ / 888.38)

Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have either a one-part radial component made of alloys, such as cobalt-chromium-molybdenum, with an ultra-high molecular weight polyethylene bearing surface, or a two-part radial component made of alloys and an ultra-high molecular weight polyethylene ball that is mounted on the radial component with a trunnion bearing. The metallic portion of the two-part radial component is inserted into the radius. These devices have a metacarpal component(s) made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (888.3027).

Classification. Class II.

Depuy Orthopaedics, Inc., Biomet, Inc, Luxtec, more...

3-Panel Knee Immobilizer
Royce Medical Company, DJ Orthopedics Inc., Restorative Care of America, Inc., more...

50 mm Securing Post
Orthofix Inc.

Abdominal Binders (FDA Code: FSD / 880.516)
Hub4Health.com, Mizuho OSI, DJ Orthopedics Inc., more...

Abdominal Orthosis (FDA Code: KTD / 890.349)

Identification. A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.

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 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, regarding general requirements concerning records and 820.198, regarding complaint files.

Biomet, Inc, Boston Brace International, Rapid Deployment Products, more...

Abdominal Panel Binders
CBS Medical, Best OrthopedicT & Medical Services, Currie Medical Specialties, Inc., more...

Abdominal Supports
Southwest Medical, DMES, Inc., DJ Orthopedics Inc., more...

Abductors Positioning Systems
Sunrise Medical, Dynatronics Corporation, Posey Company, more...

Absorbable Corkscrew Suture Anchor
Arthrex, Inc.

Absorbable Interference Screw
DePuy Orthopaedics, Inc

Absorbable Single/Multiple Component Bone Fixation Appliances And Accessories (FDA Code: MRY / 888.304)
Conmed Integrated Systems

Absorbable Staple (FDA Code: MNU / 888.303)

Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Classification. Class II.

Autosuture, Arthrex, Inc., Conmed Integrated Systems

Absorbable Suture Anchors
Autosuture, Arthrex, Inc., Biomet, Inc, more...

Absorbent Specialty Patient Drapes
Absorbent specialty patient drapes provide a vertical barrier to keep the C-arm isolated from the sterile surgical field during hip/femur fracture or trauma procedures. It helps to make draping quick and convenient by eliminating the need to drape the image intensifier.
Graham Medical

AC-Powered Cast Removal Instrument (FDA Code: LGH / 888.596)

Identification. A cast removal instrument is an AC-powered, hand-held device intended to remove a cast from a patient. This generic type of device includes the electric cast cutter and cast vacuum.

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.

Alimed, Inc., BSN medical, Inc., Aesculap Inc., more...

AC-Powered Dynamometer (FDA Code: LBB / 888.124)

Identification. An AC-powered dynamometer is an AC-powered device intended for medical purposes to assess neuromuscular function or degree of neuromuscular blockage by measuring, with a force transducer (a device that translates force into electrical impulses), the grip-strength of a patient's hand.

Classification. Class II.

Ametek, Inc., Mekanika, Inc., Specialty Therapy Equipment, Inc., more...

AC-powered Goniometer (FDA Code: KQX / 888.15)

Identification. A goniometer is an AC-powered or battery powered device intended to evaluate joint function by measuring and recording ranges of motion, acceleration, or forces exerted by a joint.

Classification. (1) Class I (general controls) for a goniometer that does not use electrode lead wires and patient cables. This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to 888.9.

Tempico, Inc., Dynatronics Corporation, Myotronics-Noromed, Inc., more...

AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE / 878.482)

Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

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 878.9.

Hayes Medical, Inc., Depuy Orthopaedics, Inc., Exactech, Inc., more...

Ac-Powered Patient Lifts (FDA Code: FNG / 880.55)

Identification. An AC-powered lift is an electrically powered device either fixed or mobile, used to lift and transport patients in the horizontal or other required position from one place to another, as from a bed to a bath. The device includes straps and slings to support the patient.

Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 880.9.

Sherman Oaks Medical Supplies, Inc, Sunrise Medical, Scooter Direct Inc., more...

Accounting/billing Software
1st Providers Choice, 5 Star Billing Services, Inc., PracticeAdmin, more...

ACE Titanium Small Fragment System
DePuy Orthopaedics, Inc

Acetabular Components
Plus Orthopaedics, Biomet, Inc, Zimmer, Inc., more...

Acetabular Cup System
DePuy Orthopaedics, Inc, OMNI life science, Inc., Whiteside Biomechanics, Inc., more...

Acetabular Liners
Acetabular liners are single-use devices intended for use in total hip replacement. It is available in various designs and sizes. It is utilized with other hip prostheses as part of a total joint system. The groove is designed to securely lock the liner into the titanium shell providing maximum push-out and lever-out strength while the rim tabs provide excellent rotational stability.
Depuy Orthopaedics, Inc., Orthomerica Products, Inc., Zimmer, Inc., more...

Acetabular Mesh Hip Prosthesis (FDA Code: JDJ / 878.33)

Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Classification. Class II.

Depuy Orthopaedics, Inc., Zimmer, Inc., DePuy Orthopaedics, Inc, more...

Achilles Tendon Strap
Ultimate Water Massage

Achilles Tendon Support Brace
Achilles tendon support brace is a dynamic sleeve-shaped ankle brace for supporting an ankle of lower extremity. It is an ankle support and protector of the achilles tendon, wherein two tendon supports are the key in assisting, rehabilitating and relieving pain within the achilles tendon by relieving pressure along the right and left sides of the achilles tendon.
Best OrthopedicT & Medical Services, Innovative Bracing, L.L.C., X-Strap Systems

ACL Cross Pin System
DePuy Orthopaedics, Inc

ACL Reconstruction Instruments
Stryker, Ethicon, Inc., Atlantech Medical Devices Ltd.

ACL Reconstruction System
ACL reconstruction system is used to repair the single most common sports-related orthopedic joint injury that is the reconstruction of the torn ACL (anterior cruciate ligament). Its unique design allows the surgeon to perform soft tissue ACL reconstruction arthroscopically, reducing both surgical time and patient trauma.
Ethicon, Inc.

ACL Soft Bracing Kit
Orthofix Inc.

Acrylic Bone Cement
Acrylic bone cement is the primary load-bearing material used for the attachment of orthopedic devices to adjoining bone. It is used as a fixing device in total hip arthroplasty and it is based on polymethyl-methacrylate.
Depuy Orthopaedics, Inc., Biomet, Inc, Bryan Corporation, more...

Active Tendon Implants
Active tendon implant consists primarily of a woven polyester core covered with silicone elastomer that provides the necessary combination of inert qualities, firmness and flexibility as well as the smooth surface required to induce pseudo-sheath formation. It ensures ease of insertion and gliding through the finger, palm, and forearm.
Wright Medical Technology, Inc.

Acupuncture
Chiropractic Plus, Inc, Multicare Rehabilitation, Fernald Chiropractic & Spinal Decompression Clinic, more...

Acupuncture Kits
Access Equipment Corp., H&w Distribution (Sensa Products), Ball Dynamics International, LLC, more...

Adapted Automobiles & Vans
Bruno Independent Living Aids Inc.

Adaptive Stroller (FDA Code: LBE / 890.385)

Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Classification. Class I (general controls).

Convaid Inc, Reha Partner Inc, Patterson Medical Products, Inc., more...

Adaptor Ring
General Physiotherapy, Inc.

Adductors Positioning Systems
Sunrise Medical, Freedom Designs Inc, Falcon Rehabilitation Products, more...

Adhesive Backed Thermal Skin Patches (FDA Code: OMW / 890.571)

Identification. A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.

Classification. Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 890.9.

Health Body World Supply, Inc., Global Tv Concepts, Ltd., Innovize, Inc., more...

Adjustable Ankle Support
Pro Orthopedic Devices, Royce Medical Company, Mizuho OSI, more...

Adjustable Arch Support
Pro Orthopedic Devices, TheReliefShop.com, Alimed, Inc., more...

Adjustable Back Brace
Adjustable back brace provides firm, comfortable support to help relieve back pain. It is ideal for back strains and sprains, moderate disc and arthritic conditions, sciatica, muscle spasms, chronic unstable lumbar spine, and strains of sacroiliac area. It consists of a pair of spaced apart support members configured to extend circumstantially about a patient's waist. Each support member has a posterior portion and an anterior portion.
Medical Department Store, Boston Brace International, Jencyn Medical Inc., more...

Adjustable Back Support
Pro Orthopedic Devices, Royce Medical Company, DJ Orthopedics Inc., more...

Adjustable Bone Holding Forceps
Rusch Inc., Autosuture, High Class Dental, more...

Adjustable Drill Guide
KLS Martin, L.P., Zimmer, Inc., Greatbatch Medical, Inc.,, more...

Adjustable Elbow Support
Adjustable elbow support provides maximum support for the elbow. It is fully adjustable, with top and bottom straps to provide customized fit and compression where needed. A soft nylon sleeve makes it easy to put on and comfortable to wear.
Pro Orthopedic Devices, IMAK Products Corp., Hub4Health.com, more...

Adjustable Exercise Weights
FitnessZone.com, Alimed, Inc., Gendron, Inc., more...

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