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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:   REAMER
Generic Device Name:   HIP CYLINDRICAL REAMER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   PUSHER, SOCKET
Generic Device Name:   RETRACTORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   ORTHOSIS, SPINAL INTERVERTEBRAL FUSION
Generic Device Name:   SPINAL FUSION DEVICE
Proprietary Device Name:   HEDROCEL, SPIRAL INTERVETEBRAL FUSION
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   PUNCH, FEMORAL NECK
Generic Device Name:   BOX OSTEOTOME
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   PROBE
Generic Device Name:   DISTAL SPACER SOUND
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   POSITIONER, SOCKET
Generic Device Name:   RETRACTORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ACETABULAR TRIAL SHELL
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   OSTEOTOME
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   INSTRUMENT, COMPRESSION
Generic Device Name:   PATELLA CLAMP
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   IMPACTOR
Generic Device Name:   BAYONET IMPACTOR HANDLE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   FORK
Generic Device Name:   HIP RETRACTOR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   FILE
Generic Device Name:   BONE FILE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   EXTRACTOR
Generic Device Name:   SLIDE HAMMER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   DRIVER, PROSTHESIS
Generic Device Name:   HIP STEM BULLET NOSE IMPACTOR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   CUTTER, WIRE
Generic Device Name:   CUTTER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   COUNTERSINK
Generic Device Name:   COUNTER SINK TAMP
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   CORKSCREW
Generic Device Name:   ACETABULAR INSERT REMOVER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   BROACH
Generic Device Name:   FEMORAL STEM BROACH
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   BRACE, DRILL
Generic Device Name:   DRILL GUIDE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   BIT, DRILL
Generic Device Name:   DRILL BIT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   AWL
Generic Device Name:   STARTER AWL
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   CALIPER
Generic Device Name:   CALIPER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   GAUGE, DEPTH
Generic Device Name:   DEPTH GAUGE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   TEMPLATE
Generic Device Name:   DRILL TEMPLATE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Generic Device Name:   CONTINUUM KNEE SYSTEM (CKS)
Proprietary Device Name:   CONTINUUM KNEE SYSTEM (CKS)
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   CINTINUUM KNEE SYSTEM (CKS)
Proprietary Device Name:   CINTINUUM KNEE SYSTEM (CKS)
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   OSCILLATING SAW BLADE
Proprietary Device Name:   CONTINUUM KNEE SYSTEM (CKS)
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Generic Device Name:   HEP REVISION CUP HEDROCEL
Proprietary Device Name:   CONTINUUM HIP SYSTEM (CHS)
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT)
Generic Device Name:   ACETABULAR CUP SYSTEM
Proprietary Device Name:   CONTINUUM HIP SYSTEM (CHS)
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   CEMENT OBTURATOR
Generic Device Name:   CEMENT RESTRICTOR SYSTEM
Proprietary Device Name:   CONTINUUM HIP SYSTEM (CHS)
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED
Generic Device Name:   F-102 ZIRCONIA-IMPEX CERAMIC HEAD
Proprietary Device Name:   CONTINUUM HIP SYSTEM (CHS)
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
Generic Device Name:   RADIAL HEAD REPLACEMENT
Proprietary Device Name:   UPPER EXTREMITY
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Generic Device Name:   HEDROCEL VERTEBRAL BODY REPLACEMENT
Proprietary Device Name:   MUSCULOSKETAL
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
Generic Device Name:   IMPLEX HEDROCEL ACETABULAR AUGMENT
Proprietary Device Name:   CONTINUUM HIP SYSTEM (CHS)
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Generic Device Name:   IMPLEX SCREW AND WASHER
Proprietary Device Name:   MUSCOLOSKELETAL
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Generic Device Name:   A-240 HEP CEMENTED HEDROCEL
Proprietary Device Name:   CONTINUUM HIP SYSTEM (CHS)
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   RONGEUR
Generic Device Name:   RONGEUR, STRAIGHT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   SCREWDRIVER
Generic Device Name:   ACETABULAR SCREW DRIVER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   STARTER, BONE SCREW
Generic Device Name:   DRILL BIT STARTER TIP
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.

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Last Modified: 29 April 2006
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