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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:   PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICUM-PHOSPHATE
Generic Device Name:   CEMENTLESS HIP STEM
Proprietary Device Name:   LINEAR POROUS COATED HIP STEM, FOUNDATION POROUS COATED HIP STEM, REVELATION POR
Registered Establishment Name:  ENCORE MEDICAL, L.P..
Classification:   PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
Generic Device Name:   KNEE SYSTEM
Proprietary Device Name:   3DKNEE
Registered Establishment Name:  ENCORE MEDICAL, L.P..
Classification:   PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
Generic Device Name:   CONSTRAINED LINER
Proprietary Device Name:   CONSTRAINED LINER
Registered Establishment Name:  ENCORE MEDICAL, L.P..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE
Generic Device Name:   SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCES AND ACCESSORIES
Proprietary Device Name:   TRUE/LOK MONOLATERAL/BILATERAL FIXATOR
Registered Establishment Name:  ENCORE MEDICAL, L.P..
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Proprietary Device Name:   CYCLONE
Registered Establishment Name:  ENCORE MEDICAL, L.P..
Classification:   PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
Generic Device Name:   PRESS-FIT HUMERAL STEM
Proprietary Device Name:   FOUNDATION HEMI SHOULDER
Registered Establishment Name:  ENCORE MEDICAL, L.P..
Classification:   SCREWDRIVER
Generic Device Name:   SCREWDRIVER
Proprietary Device Name:   ENCORE SCREWDRIVER
Registered Establishment Name:  ENCORE MEDICAL, L.P..
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Proprietary Device Name:   SELBY (VARIFIX)
Registered Establishment Name:  ENCORE MEDICAL, L.P..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
Generic Device Name:   PROSTHESIS, HIP
Proprietary Device Name:   Z-SERIES MODULAR HIP
Registered Establishment Name:  ENCORE MEDICAL, L.P..
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   PEDICLE SCREW SPINAL SYSTEM
Proprietary Device Name:   SELBY (VARIFIX)
Registered Establishment Name:  ENCORE MEDICAL, L.P..
Classification:   REAMER
Generic Device Name:   VARIOUS TYPES OF REAMERS
Proprietary Device Name:   ENCORE REAMERS
Registered Establishment Name:  ENCORE MEDICAL, L.P..
Classification:   BROACH
Generic Device Name:   VARIOUS TYPES OF BROACHES
Proprietary Device Name:   ENCORE BROACHES
Registered Establishment Name:  ENCORE MEDICAL, L.P..
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEURS
Proprietary Device Name:   ENCORE RONGEURS
Registered Establishment Name:  ENCORE MEDICAL, L.P..
Classification:   IMPACTOR
Generic Device Name:   VARIOUS TYPES OF IMPACTORS
Proprietary Device Name:   ENCORE IMPACTORS
Registered Establishment Name:  ENCORE MEDICAL, L.P..
Classification:   TEMPLATE
Generic Device Name:   TEMPLATE
Proprietary Device Name:   ENCORE TEMPLATE
Registered Establishment Name:  ENCORE MEDICAL, L.P..
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEURS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ROBERT MUELLER INSTRUMENTE.
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   NO COMMON NAME LISTED
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  FAUSTINO RINCON.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   DOUBLE ENDED FORAMINAL PROBE; POSTERIOR DISC EVACUATOR
Proprietary Device Name:   AMSEN
Registered Establishment Name:  ADVANCED SPINE TECHNOLOGY, INC..
Classification:   IMPLANT, FIXATION DEVICE, SPINAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ADVANCED SPINE TECHNOLOGY, INC..
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   TRIFIX SYSTEM
Proprietary Device Name:   TRI-FIX SPINAL FIXATION SYSTEM
Registered Establishment Name:  ADVANCED SPINE TECHNOLOGY, INC..
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   TRIPLEFIX SYSTEM
Proprietary Device Name:   TRIFIX SPINAL FIXATION SYSTEM
Registered Establishment Name:  ADVANCED SPINE TECHNOLOGY, INC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   WINDOW CERVICAL DYNAMIC PLATE SYSTEM
Proprietary Device Name:   WINDOW CERVICAL DYNAMIC PLATE SYSTEM
Registered Establishment Name:  ADVANCED SPINE TECHNOLOGY, INC..
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   FIXATION PIN
Proprietary Device Name:   STEINMANN PIN
Registered Establishment Name:  SIMPEX MEDICAL, INC..
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   FIXATION PIN
Proprietary Device Name:   THREADED STEINMANN PIN
Registered Establishment Name:  SIMPEX MEDICAL, INC..
Classification:   BIT, DRILL
Generic Device Name:   DRILL, SURGICAL, ORTHOPEDIC
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  PETER BUMUELLER.
Classification:   CALIPER
Generic Device Name:   VARIOUS TYPES OF CALIPERS
Proprietary Device Name:   MULTIPLE PRIVATE LABEL
Registered Establishment Name:  PETER BUMUELLER.
Classification:   BRACE, DRILL
Generic Device Name:   VARIOUS TYPES OF DRILLS
Proprietary Device Name:   MULTIPLE PRIVATE LABEL
Registered Establishment Name:  PETER BUMUELLER.
Classification:   CALIPER
Generic Device Name:   CALIPER
Registered Establishment Name:  SASCO, INC..
Classification:   DYNAMOMETER, AC-POWERED
Generic Device Name:   SPINAL STIFFNESS GAUGE
Proprietary Device Name:   SPINAL STIFFNESS GAUGE
Registered Establishment Name:  MEKANIKA, INC..
Classification:   BIT, DRILL
Generic Device Name:   BONE DRILL BIT
Proprietary Device Name:   SAFEPATH
Registered Establishment Name:  MEKANIKA, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   RICHBOLT ENTERPRISES
Registered Establishment Name:  RICHBOLT ENTERPRISES.
Classification:   CUTTER, WIRE
Generic Device Name:   WIRE CUTTER
Proprietary Device Name:   RICHBOLT ENTERPRISES
Registered Establishment Name:  RICHBOLT ENTERPRISES.
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   COMPONENT FOR EXTERNAL FIXATION DEVICE
Proprietary Device Name:   AUTOGENESIS(TM) AUTOMATOR(TM)
Registered Establishment Name:  AUTOGENESIS, INC..
Classification:   COMPONENT, TRACTION, INVASIVE
Generic Device Name:   AUTOMATIC DISTRACTION COMPONENT FOR EXTERNAL FIXATION DEVICES
Proprietary Device Name:   AUTOGENESIS AUTOMATOR 2000
Registered Establishment Name:  AUTOGENESIS, INC..
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   AUTOMATIC DISTRACTION COMPONENT FOR EXTERNAL FIXATION DEVICES
Proprietary Device Name:   CF AUTOMATOR
Registered Establishment Name:  AUTOGENESIS, INC..
Classification:   ARTHROSCOPE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCICAN.
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   PELVIC TRACTION BELT
Registered Establishment Name:  KENAD SG MEDICAL, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   ORTHOPEDIC SCISSORS
Registered Establishment Name:  KENAD SG MEDICAL, INC..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   FIXATION DEVICES (BONE SCREWS AND OTHER COMPONENTS)
Registered Establishment Name:  SUPREME SCREW PRODUCTS, INC..
Classification:   PROBE
Generic Device Name:   COAGULATION PROBE
Proprietary Device Name:   COAGULATION PROBE
Registered Establishment Name:  UNITED STATES ENDOSCOPY GROUP, INC..

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Last Modified: 29 April 2006
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