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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, METAL/POLYMER, UNCEMENTED
Generic Device Name:   VARIOUS SIZES & DESIGNS OF FEMORAL HIP STEMS
Proprietary Device Name:   UNI-STEM HIP PROSTHESIS, MODULAR PLUS REVISION STEMS, SL-PLUS LATERALIZED STEMS
Registered Establishment Name:  PLUS ORTHOPEDICS AG.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED
Generic Device Name:   VARIOUS SIZES & DESIGNS OF ACETABULAR CUPS, INSERTS AND BALL HEADS
Proprietary Device Name:   BOFOR REVISION CUP, MPF ACETABULAR CUPS GEN II, MPF ACETABULAR CUPS
Registered Establishment Name:  PLUS ORTHOPEDICS AG.
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   CALCIUM SULFATE
Proprietary Device Name:   STIMULAN
Registered Establishment Name:  BIOCOMPOSITES LTD..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BIORESORBABLE INTERFERENCE SCREW
Proprietary Device Name:   BILOK SCREW
Registered Establishment Name:  BIOCOMPOSITES LTD..
Classification:   STARTER, BONE SCREW
Generic Device Name:   TUNNEL DILATOR
Proprietary Device Name:   BILOK DILATOR
Registered Establishment Name:  BIOCOMPOSITES LTD..
Classification:   TAP, BONE
Generic Device Name:   ACL BONE TAP
Proprietary Device Name:   BILOK TAP
Registered Establishment Name:  BIOCOMPOSITES LTD..
Classification:   SCREWDRIVER
Generic Device Name:   SCREWDRIVER
Proprietary Device Name:   BILOK DRIVER
Registered Establishment Name:  BIOCOMPOSITES LTD..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ALLOFIX CORTICAL BONE PIN INSERTION KIT
Proprietary Device Name:   ALLOFIX CORTICAL BONE PIN INSERTION KIT
Registered Establishment Name:  MUSCULOSKELETAL TRANSPLANT FOUNDATION.
Classification:   GAUGE, DEPTH
Generic Device Name:   SBS" TRIAL SPACER
Proprietary Device Name:   SBS" TRIAL SPACER
Registered Establishment Name:  MUSCULOSKELETAL TRANSPLANT FOUNDATION.
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   BONE VOID FILLER CONTAINING HUMAN DEMINERALIZED MATRIX
Proprietary Device Name:   DBX STRIP
Registered Establishment Name:  MUSCULOSKELETAL TRANSPLANT FOUNDATION.
Classification:   PROSTHESIS, TOE, HEMI-, PHALANGEAL
Generic Device Name:   PHALANGEAL JOINT IMPLANT
Proprietary Device Name:   SILIMED PHALANGEAL JOINT IMPLANT
Registered Establishment Name:  SILIMED-SILICONE E INSTRUMENTAL MEDICO-CIRURGICO E.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   PLEASANT SURGICO
Registered Establishment Name:  PLEASANT SURGICO.
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   ORIA SPINAL CLIP SYSTEM
Proprietary Device Name:   ORIA SPINAL CLIP SYSTEM
Registered Establishment Name:  EUROSURGICAL S.A..
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   ORIA SPINAL CLIP SYSTEM
Proprietary Device Name:   ORIA SPINAL CLIP SYSTEM
Registered Establishment Name:  EUROSURGICAL S.A..
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   ORIA SPINAL CLIP SYSTEM
Proprietary Device Name:   ORIA SPINAL CLIP SYSTEM
Registered Establishment Name:  EUROSURGICAL S.A..
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   ORIA SPINAL CLIP SYSTEM
Proprietary Device Name:   ORIA SPINAL CLIP SYSTEM
Registered Establishment Name:  EUROSURGICAL S.A..
Classification:   SCREWDRIVER
Generic Device Name:   VARIOUS SIZES OF CRUCIFORM SCREWDRIVERS
Proprietary Device Name:   CRUCIFORM SCREWDRIVER
Registered Establishment Name:  DOCTOR'S RESEARCH GROUP, INC..
Classification:   FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Generic Device Name:   THREADED METALLIC BONE FIXATION FASTENER, VARIOUS TYPES & SIZES
Proprietary Device Name:   SHERLOCK THREADED SUTURE ANCHOR
Registered Establishment Name:  DOCTOR'S RESEARCH GROUP, INC..
Classification:   BONE CEMENT
Generic Device Name:   BONE CEMENT, BONE VOID FILLER
Proprietary Device Name:   DRG KRYPTONITE BONE CEMENT
Registered Establishment Name:  DOCTOR'S RESEARCH GROUP, INC..
Classification:   PROSTHESTIC DISC NUCLEUS DEVICE
Generic Device Name:   PROSTHETIC DISC NUCLEUS DEVICE
Proprietary Device Name:   PDN PROSTHETIC DISC NUCLEUS
Registered Establishment Name:  RAYMEDICA, INC..
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE AND ACCESSORIES
Proprietary Device Name:   ARTHROSCOPE IRRIGATION SYSTEM
Registered Establishment Name:  DAVOL SURGICAL INNOVATIONS.
Classification:   BIT, DRILL
Generic Device Name:   TWIST DRILL
Proprietary Device Name:   TWIST DRILL
Registered Establishment Name:  SPHINX TOOLS LTD..
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   PEDICLE SCREW SPINAL SYSTEM
Proprietary Device Name:   GII SPINAL FIXATION SYSTEM
Registered Establishment Name:  CO-LIGNE AG.
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   SPINAL INTERLAMINAL FIXATION ORTHOSIS
Proprietary Device Name:   GII SPINAL FIXATION SYSTEM
Registered Establishment Name:  CO-LIGNE AG.
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   PEDICLE SCREW SPINAL SYSTEM
Proprietary Device Name:   GII SPINAL FIXATION SYSTEM
Registered Establishment Name:  CO-LIGNE AG.
Classification:   GAUGE, DEPTH
Generic Device Name:   DEPTH GAUGE VARIOUS SIZES
Proprietary Device Name:   DEPTH GAUGE
Registered Establishment Name:  GENERAL SURGICAL CO., (INDIA) PVT. LTD..
Classification:   REAMER
Generic Device Name:   BONE-REAMER
Proprietary Device Name:   REAMER-BONE
Registered Establishment Name:  GENERAL SURGICAL CO., (INDIA) PVT. LTD..
Classification:   STARTER, BONE SCREW
Generic Device Name:   STARTER FOR SCREW - BONE
Proprietary Device Name:   BONE SCREW STARTER
Registered Establishment Name:  GENERAL SURGICAL CO., (INDIA) PVT. LTD..
Classification:   DRIVER, PROSTHESIS
Generic Device Name:   PROSTHESIS DRIVING INSTRUMENT
Proprietary Device Name:   PROSTHESIS DRIVER
Registered Establishment Name:  GENERAL SURGICAL CO., (INDIA) PVT. LTD..
Classification:   TAP, BONE
Generic Device Name:   BONE TAP ALL SIZES
Proprietary Device Name:   TAP, BONE
Registered Establishment Name:  GENERAL SURGICAL CO., (INDIA) PVT. LTD..
Classification:   TWISTER, WIRE
Generic Device Name:   WIRE TWISTER- ALL TYPES AND SIZES
Proprietary Device Name:   WIRE TWISTER
Registered Establishment Name:  GENERAL SURGICAL CO., (INDIA) PVT. LTD..
Classification:   PASSER, WIRE, ORTHOPEDIC
Generic Device Name:   ORTHOPEDIC WIRE PASSER
Proprietary Device Name:   ORTHOPEADIC WIRE PASSER
Registered Establishment Name:  GENERAL SURGICAL CO., (INDIA) PVT. LTD..
Classification:   BRACE, DRILL
Generic Device Name:   DRILL BRACE ALL TYPES
Proprietary Device Name:   DRILL BRACE
Registered Establishment Name:  GENERAL SURGICAL CO., (INDIA) PVT. LTD..
Classification:   CUTTER, WIRE
Generic Device Name:   WIRE CUTTER-ALL TYPES
Proprietary Device Name:   WIRE CUTTER
Registered Establishment Name:  GENERAL SURGICAL CO., (INDIA) PVT. LTD..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC SURGICAL INSTRUMENTS - MANUAL ALL TYPES & SIZES
Proprietary Device Name:   ORTHOPEDIC SURGICAL INSTRUMENTS - MANUAL
Registered Establishment Name:  GENERAL SURGICAL CO., (INDIA) PVT. LTD..
Classification:   ARTHROSCOPE
Generic Device Name:   TUBING SET
Proprietary Device Name:   MTP ARTHROPUMP TUBING SET
Registered Establishment Name:  EMS MEDICAL, INC..
Classification:   COMPONENT, TRACTION, NON-INVASIVE
Generic Device Name:   VERTEBRAL DISTRACTION PUMP (V.D.P.)
Proprietary Device Name:   VERTEBRAL DISTRACTION PUMP (V.D.P.)
Registered Establishment Name:  BRAY CORPORATION.
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   VARIOUS TYPES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HU-FRIEDY MFG. CO.,INC..
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   VARIOUS ORTHOPEDIC KNIVES,STERILE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDISISS.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS,STERILE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDISISS.

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Last Modified: 29 April 2006
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