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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:   CERCLAGE, FIXATION
Generic Device Name:   PARHAM BANDS AND SOFT AND HARD WIRE FOR CERCLAGE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   GAUGE, DEPTH
Generic Device Name:   VARIOUS TYPES AND SIZES OF DEPTH GAUGES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   IMPACTOR
Generic Device Name:   VARIOUS TYPES OF IMPACTORS (DRIVERS) AND IMPACTOR/EXTRACTOR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
Generic Device Name:   VARIOUS TYPES OF CONDYLAR PLATES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   INSTRUMENT, BENDING OR CONTOURING
Generic Device Name:   BENDING PRESS, BENDING CLAMPS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   CORKSCREW
Generic Device Name:   CORKSCREWS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   COUNTERSINK
Generic Device Name:   VARIOUS SIZES OF COUNTERSINKS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   CRIMPER, PIN
Generic Device Name:   VARIOUS SIZES OF CRIMPERS AND PINS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS TYPES OF WIRE CUTTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Generic Device Name:   MULTIPLE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   PASSER
Generic Device Name:   PASSERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   VARIOUS TYPES AND SIZES OF STERILE AND NON-STERILE SMOOTH AND WIRES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   VARIOUS TYPES AND SIZES OF THREADED PINS AND WIRES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
Generic Device Name:   TOTAL ELBOW PROTHESES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   VARIOUS TYPES AND SIZES OF NON-CONSTRAINED METAL/POLY DEVICES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
Generic Device Name:   VARIOUS TYPES OF SHOULDER PROSTHESES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
Generic Device Name:   VARIOUS TYPES OF SHOULDER PROSTHESES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   PROTRACTOR
Generic Device Name:   PROTRACTORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   PUSHER, SOCKET
Generic Device Name:   VARIOUS TYPES OF SOCKET PUSHERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   REAMER
Generic Device Name:   VARIOUS TYPES AND SIZES OF REAMERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT)
Generic Device Name:   DENTAL BONE PLATE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICUM-PHOSPHATE
Generic Device Name:   BIOLOGICAL INGROWTH, FEMORAN STEMS, ACETABULAR CUPS, HA/TCP COATED
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
Generic Device Name:   SHOULDER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, COMPOSITE/POLYMER
Generic Device Name:   HIP PROSTHESIS, EXTENSIVELY POROUS-COATED, COMPOSITE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCEMENTED
Generic Device Name:   CERAMIC INSERT/HEADS, ACETABULAR SHELLS (ALTERNATE BEARING )
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
Generic Device Name:   VARIOUS TYPES OF SEMI-CONSTRAINED ELBOW PROSTHESES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
Generic Device Name:   HIP JOINT FEMORAL (HEMI-HIP) METALLIC, CEMENTED OR UNCEMENTED PROSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Generic Device Name:   BIOLOGICAL INGROWTH ANATOMIC HIP STEM, FEMORAL STEMS, ACETABULAR CUPS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
Generic Device Name:   HIP JOINT METAL/POLYMER SEMI-CONSTRAINED UNCEMENTED PROSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Generic Device Name:   HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR CEMENTED OR UNCEMENTED PR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   PIN, FIXATION, SMOOTH, METALLIC
Generic Device Name:   VARIOUS TYPES AND SIZES OF STERILE AND NON-STERILE SMOOTH PINS AND WIRES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS)
Generic Device Name:   VARIOUS TYPES OF TRACTION, INVASIVE DEVICES AND ACCESSORIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   STAPLE, FIXATION, BONE, METALLIC
Generic Device Name:   VARIOUS TYPES AND SIZES OF STAPLES AND ACCESSORIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   PIN, FIXATION, THREADED, METALLIC
Generic Device Name:   VARIOUS TYPES AND SIZES OF THREADED PINS AND WIRES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   WASHER, BOLT, NUT, NON-SPINAL, METALLIC
Generic Device Name:   VARIOUS TYPES AND SIZES OF BOLTS, NUTS, AND WASHERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   NAIL, FIXATION, BONE, METALLIC
Generic Device Name:   VARIOUS TYPES AND SIZES OF SLIDING AND NONSLIDING BONE NAILS AND NAIL/PLATE COMS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   CERCLAGE, FIXATION, METALLIC
Generic Device Name:   PARHAM BANDS AND SOFT AND HARD WIRE FOR CERCLAGE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   PLATE, FIXATION, BONE, NON-SPINAL, METALLIC
Generic Device Name:   VARIOUS TYPES AND SIZES OF BONE PLATES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES, METALLIC AND NON-COLLAPSIBLE
Generic Device Name:   VARIOUS TYPES AND SIZES OF INTRAMEDULLARY NAILS, PINS, AND SETS CONTAINING VARIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER, INC..

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Last Modified: 29 April 2006
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