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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:   ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Generic Device Name:   PEDICLE SCREW SYSTEM
Proprietary Device Name:   SPINAL FIXATION SYSTEM, MULTIPLE
Registered Establishment Name:  ENDIUS, INC..
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   PEDICLE SCREW SYSTEM
Proprietary Device Name:   SPINAL FIXATION SYSTEM, MULTIPLE
Registered Establishment Name:  ENDIUS, INC..
Classification:   COMPONENT, TRACTION, NON-INVASIVE
Generic Device Name:   SHOULDER TRAC
Proprietary Device Name:   SHOULDER TRAC
Registered Establishment Name:  CIMEX BIOTECH, LLC..
Classification:   NAIL, FIXATION, BONE
Generic Device Name:   CORTICAL BONE SCREW
Proprietary Device Name:   LOW PROFILE CORTICAL BONE SCREW
Registered Establishment Name:  TRIMED, INC..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   SMALL FRAGMENT PLATE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  TRIMED, INC..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   SMALL FRAGMENT FIXATION SYSTEM
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  TRIMED, INC..
Classification:   TEMPLATE
Generic Device Name:   TEMPLATE FOR CLINICAL USE
Proprietary Device Name:   S.A.F.E. MEDICAL OSTEOTOMY GUIDES
Registered Establishment Name:  S.A.F.E. MEDICAL PRODUCTS, L.L.C..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDICS INSTRUMENTS
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  PLUS ORTHOPEDICS USA, INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   A NON-POWERED ORTHOPEDIC TRACTION APPARATUS
Proprietary Device Name:   BACK BUBBLE
Registered Establishment Name:  BACK BUBBLE.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   TATA SERVICES
Registered Establishment Name:  TATA SERVICES.
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE
Proprietary Device Name:   MR COMPATIBLE ARTHROSCOPE AND SMALL JOINT ARTHROSCOPE
Registered Establishment Name:  MINRAD, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   TMJ FIXATION INSTRUMENTS
Registered Establishment Name:  TMJ SOLUTIONS, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS CEMENTED, OSTEOPHILIC FINISH
Generic Device Name:   MRP-TITAN
Proprietary Device Name:   MRP-TITAN
Registered Establishment Name:  PETER BREHM GMBH CHIRUGIE MECHANIK.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Generic Device Name:   MRS-TITAN
Proprietary Device Name:   MRS-TITAN
Registered Establishment Name:  PETER BREHM GMBH CHIRUGIE MECHANIK.
Classification:   CALIPER
Generic Device Name:   CALIPERS FOR CLINICAL USE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  GOLDEN HORSE MEDICAL EQUIPMENT (WUXI) CO. LTD..
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE AND ACCESSORIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ANTJE TONTARRA.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   PAMEXLAND INTERNATIONAL
Registered Establishment Name:  PAMEXLAND INTERNATIONAL.
Classification:   AWL
Generic Device Name:   VARIOUS TYPES OF AWL
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DCV INSTRUMENTE GMBH.
Classification:   PROBE
Generic Device Name:   VARIOUS TYPES OF PROBES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DCV INSTRUMENTE GMBH.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  HUMERA SANKYO CORPORATION.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   PLASTIC HANDLE SCISSORS
Proprietary Device Name:   LONJYFAN PLASTIC HANDLE SCISSORS
Registered Establishment Name:  LONJYFAN ENTERPRISE CORP..
Classification:   TAP, BONE
Generic Device Name:   TAP SLEEVE
Proprietary Device Name:   TAP, BONE (MULTIPLE BRANDS)
Registered Establishment Name:  OTTO LEIBINGER GMBH.
Classification:   TAMP
Generic Device Name:   BONE TAMP
Proprietary Device Name:   TAMP (MULTIPLE BRANDS)
Registered Establishment Name:  OTTO LEIBINGER GMBH.
Classification:   IMPACTOR
Generic Device Name:   GRAFT IMPACTOR
Proprietary Device Name:   MULTIPLE, VARIOUS
Registered Establishment Name:  OTTO LEIBINGER GMBH.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ABLE BROTHERS.
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   GONIOMETER
Proprietary Device Name:   ROLIMETR
Registered Establishment Name:  AIRCAST LLC.
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   COMPRESSION HIP SCREW SYSTEM
Proprietary Device Name:   VHS- VARI-ANGLE HIP SYSTEM
Registered Establishment Name:  IMPLANT DISTRIBUTION NETWORK, LTD..
Classification:   COMPONENT, CAST
Generic Device Name:   CAST PROTECTOR OR SUPPORTER
Proprietary Device Name:   VARIOUS SIZES OF CAST WALKER KIT
Registered Establishment Name:  HEALTH CARE LOGISTICS, INC..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   COMPRESSION HIP NAIL
Proprietary Device Name:   SLIM GLIDING NAIL SYSTEM
Registered Establishment Name:  PLUS ORTHOPEDICS AG.
Classification:   PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   UNICONDYLAR KNEE
Proprietary Device Name:   UC-PLUS SOLUTION KNEE
Registered Establishment Name:  PLUS ORTHOPEDICS AG.
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   INTRAMEDULLARY FIXATION ROD
Proprietary Device Name:   IP-XS COMPRESSION NAIL SYSTEM
Registered Establishment Name:  PLUS ORTHOPEDICS AG.
Classification:   PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
Generic Device Name:   HEMI OR TOTAL SHOULDER - HUMERAL
Proprietary Device Name:   PROMOS SHOULDER
Registered Establishment Name:  PLUS ORTHOPEDICS AG.
Classification:   PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
Generic Device Name:   HEMI OR TOTAL SHOULDER - GLENOIDS & BALL HEADS
Proprietary Device Name:   PROMOS SHOULDER
Registered Establishment Name:  PLUS ORTHOPEDICS AG.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BONE SCREWS - VARIOUS SIZES
Proprietary Device Name:   PLUS CANCELLOUS BONE SCREW
Registered Establishment Name:  PLUS ORTHOPEDICS AG.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Generic Device Name:   ALL PE ACETABULAR CUPS, CEMENTED HIP STEMS
Proprietary Device Name:   PE - PLUS ACETABULAR CUP, PLUS ORTHOPEDICS CEMENTED HIP STEM
Registered Establishment Name:  PLUS ORTHOPEDICS AG.
Classification:   PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Generic Device Name:   VARIOUS SIZES & COMPONENTS OF TOTAL KNEE PROSTHESIS
Proprietary Device Name:   TC-PLUS SOLUTION KNEE, VKS KNEE SYSTEM, VKS/TC-PLUS REVISION KNEE
Registered Establishment Name:  PLUS ORTHOPEDICS AG.
Classification:   PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   ROTATING HINGE KNEE SYSTEM
Proprietary Device Name:   RT-PLUS SOLUTION KNEE SYSTEM
Registered Establishment Name:  PLUS ORTHOPEDICS AG.
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
Generic Device Name:   UNIPOLAR HEAD
Proprietary Device Name:   PLUS UNIPOLAR HEAD, PLUS FRACTURE HEAD
Registered Establishment Name:  PLUS ORTHOPEDICS AG.
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Generic Device Name:   BIPOLAR HEAD
Proprietary Device Name:   PLUS BIPOLAR HEAD
Registered Establishment Name:  PLUS ORTHOPEDICS AG.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS
Proprietary Device Name:   PLUS MANUAL SURGICAL INSTRUMENTS
Registered Establishment Name:  PLUS ORTHOPEDICS AG.

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Last Modified: 29 April 2006
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