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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
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   INSTRUMENT, COMPRESSION
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   WRENCH
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   COUNTERSINK
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   RONGEUR
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   BENDER
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   DISPENSER, CEMENT
Generic Device Name:   NON-POWERED SYRINGE-LIKE CEMENT DISPENSER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   CEMENT OBTURATOR
Generic Device Name:   VARIOUS TYPES AND SIZES OF INTRAMEDULLARY PLUGS, ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   BONE MILL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
Generic Device Name:   PRESS-FIT HUMERAL STEM
Proprietary Device Name:   ANATOMICA PRESS-FIT HUMERAL STEM
Registered Establishment Name:  ZIMMER GMBH.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
Generic Device Name:   METAL-ON-METAL ACETABULAR INSERTS
Proprietary Device Name:   METASUL ACETABULAR INSERTS
Registered Establishment Name:  ZIMMER GMBH.
Classification:   PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   UNICOMPARTMENTAL KNEE SYSTEM
Proprietary Device Name:   ALLEGRETTO UNICOMPARTMENTAL KNEE SYSTEM
Registered Establishment Name:  ZIMMER GMBH.
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Generic Device Name:   HIP PROTHESIS, VARIOUS SIZES AND TYPES
Proprietary Device Name:   ALLOCLASSIC(ZWEYMUELLER) HIP PROSTHESIS
Registered Establishment Name:  ZIMMER GMBH.
Classification:   POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION
Generic Device Name:   PEDICLE SCREW SPINAL SYSTEM
Proprietary Device Name:   DYNESYS SPINAL SYSTEM
Registered Establishment Name:  ZIMMER GMBH.
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
Generic Device Name:   METAL PROSTHETIC HIP STEM
Proprietary Device Name:   ALLOCLASSIC(TM) ZWEYMULLER(TM) SL OFFSET STEM
Registered Establishment Name:  ZIMMER GMBH.
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   BONE FIXATION PLATE
Proprietary Device Name:   NCB PLATING SYSTEM
Registered Establishment Name:  ZIMMER GMBH.
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   INTRAMEDULLARY FIXATION ROD
Proprietary Device Name:   SIRUS NAIL SYSTEM
Registered Establishment Name:  ZIMMER GMBH.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   SURGICAL INSTRUMENT
Proprietary Device Name:   CEMENT AND BONE REMOVAL KIT
Registered Establishment Name:  MAILLEFER INSTRUMENTS HOLDING SA.
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   JOTA
Registered Establishment Name:  JOTA AG.
Classification:   RONGEUR
Generic Device Name:   VARIOUS
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  ULRICH AG.
Classification:   IMPACTOR
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ULRICH AG.
Classification:   TWISTER, WIRE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ULRICH AG.
Classification:   SCREWDRIVER
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ULRICH AG.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ULRICH AG.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS, ORTHOPEDIC, SURGICAL
Registered Establishment Name:  PAKISTAN SURGICAL INDUSTRIES (PVT) LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS SIZES AND STYLES ORTHOPEDIC SCISSORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  GRAND PRIX SURGICO (R).
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS SIZES AND STYLES OF ORTHOPEDIC SCISSORS
Proprietary Device Name:   SCISSORS, ORTHOPEDIC
Registered Establishment Name:  S. SAQALAIN INDUSTRIES PVT. LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS SIZES AND STYLES OF ORTHOPEDIC SCISSORS
Proprietary Device Name:   SCISSORS, ORTHOPEDIC
Registered Establishment Name:  QSA SURGICAL, LTD..
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES AND SIZES OF RONGEUR
Proprietary Device Name:   RONGEUR (MULTIPLE BRANDS)
Registered Establishment Name:  QSA SURGICAL, LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS SIZES AND STYLES OF ORTHOPEDIC SCISSORS
Proprietary Device Name:   SCISSORS, ORTHOPEDIC
Registered Establishment Name:  ENDURA INDUSTRIES.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  RATCHER & CO..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   VARIOUS SIZES OF SLOTTED WEIGHT
Proprietary Device Name:   SLOTTED WEIGHT PC2586A, PC2586B, PC2586C
Registered Establishment Name:  SAEHAN CORPORATION.

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Last Modified: 29 April 2006
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