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US Food and Drug Administration (FDA) - Orthopedic Devices Registration

FDA Registered Orthopedic Devices - Updated May 2006

What Is Medical Device Listing?

Most medical device establishments required to register with FDA must also identify to FDA the devices they have in commercial distribution including devices produced exclusively for export. This process is known as medical device listing and is a means of keeping FDA advised of the generic category(s) of devices an establishment is manufacturing or marketing.
FDA Devices
FDA Devices
FDA Devices
FDA Devices


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Classification:   GAUGE, DEPTH
Generic Device Name:   VARIOUS TYPES OF DEPTH GAUGES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Generic Device Name:   VARIOUS TYPES OF HIP PROSTHESES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   VARIOUS TYPES OF TRACTION APPARATUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED
Generic Device Name:   VARIOUS TYPES OF HIP PROSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
Generic Device Name:   VARIOUS TYPES OF HIP PROSTHESES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   TEMPLATE
Generic Device Name:   VARIOUS TYPES OF TEMPLATES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
Generic Device Name:   VARIOUS TYPES OF SHOULDER PROSTHESES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   BONE CEMENT
Generic Device Name:   BONE CEMENT
Proprietary Device Name:   VERSABOND
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   PROSTHESIS, UPPER FEMORAL
Generic Device Name:   VARIOUS TYPES OF FEMORAL PROSTHESES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Generic Device Name:   VARIOUS TYPES OF HIP COMPONENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
Generic Device Name:   VARIOUS TYPES OF HUMERAL COMPONENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE
Generic Device Name:   VARIOUS TYPES OF FIXATION APPLIANCES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   VARIOUS TYPES OF INTRAMEDULLARY FIXATION RODS AND ACCESSORIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   WASHER, BOLT NUT
Generic Device Name:   VARIOUS TYPES OF WASHERS, BOLTS, NUTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF BONE FIXATION SCREWS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   CERCLAGE, FIXATION
Generic Device Name:   VARIOUS TYPES OF FIXATION CERCLAGE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF BONE FIXATION STAPLES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   COMPONENT, TRACTION, INVASIVE
Generic Device Name:   VARIOUS TYPES OF INVASIVE TRACTION COMPONENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICUM-PHOSPHATE
Generic Device Name:   VARIOUS TYPES OF NON-POROUS, CALCIUM-PHOSPHATE HIP PROSTHESES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   VARIOUS TYPES OF CALCIUM SULFATE FILLER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   VARIOUS TYPES OF KNEE PROSTHESES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
Generic Device Name:   VARIOUS TYPES OF HIP FEMORAL COMPONENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Generic Device Name:   VARIOUS TYPES OF HIP COMPONENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Generic Device Name:   VARIOUS TYPES OF KNEE PROSTHESES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF BONE FIXATION PLATES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   VARIOUS TYPES OF THREADED FIXATION PINS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   VARIOUS TYPES OF SMOOTH FIXATION PINS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   VARIOUS TYPES OF FIXATION APPLIANCES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
Generic Device Name:   VARIOUS TYPES OF UNCEMENTED POROUS COATED KNEE PROSTHESES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   NAIL, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF BONE FIXATION NAILS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
Generic Device Name:   VARIOUS TYPES OF CONSTRAINED HIP PROSTHESES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   CEMENT OBTURATOR
Generic Device Name:   VARIOUS TYPES OF CEMENT OBTURATORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   PATELLO-FEMORAL KNEE PROSTHESIS
Proprietary Device Name:   PATELLO-FEMORAL KNEE PROSTHESIS
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Generic Device Name:   PATELLOFEMOROTIBIAL KNEE PROSTHESIS
Proprietary Device Name:   HYBRID KNEE PROSTHESIS
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCEMENTED
Generic Device Name:   SEMI-CONSTRAINED HIP PROSTHESIS
Proprietary Device Name:   REFLECTION CERAMIC ACETABULAR COMPONENTS
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Generic Device Name:   VARIOUS TYPES OF CEMENTED OR UNCEMENTED METAL/POLYMER FEMORAL HEMI-HIP PROSTHESE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SANORTHO, SA.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SANORTHO, SA.
Classification:   COMPONENT, TRACTION, INVASIVE
Generic Device Name:   VARIOUS TYPES OF INVASIVE TRACTION COMPONENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SANORTHO, SA.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW ORTHOPAEDICS, GMBH.
Classification:   DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW ORTHOPAEDICS, GMBH.

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Last Modified: 29 April 2006
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