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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:   SPINAL FIXATION SYSTEM
Proprietary Device Name:   ARRAY SPINAL FIXATION SYSTEM AND SPINELINK II
Registered Establishment Name:  EBI, L.P..
Classification:   ACCESSORIES,ARTHROSCOPIC
Generic Device Name:   VARIOUS ATHROSCOPIC ACCESSORIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  EBI, L.P..
Classification:   NAIL, FIXATION, BONE, METALLIC
Generic Device Name:   BONE PLATE FIXATION SYSTEM
Proprietary Device Name:   DYNAFIX VS OSTEOTOMY SYSTEM
Registered Establishment Name:  EBI, L.P..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE
Generic Device Name:   EXTERNAL FIXATION DEVICE
Proprietary Device Name:   XFIX DFS SYSTEM
Registered Establishment Name:  EBI, L.P..
Classification:   CRIMPER, PIN
Generic Device Name:   PIN COVERS
Proprietary Device Name:   PIN-GUARDS
Registered Establishment Name:  TRIAD MEDICAL, INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   ACCESSORIES, TRACTION CART, FRAME, CORD WEIGHT
Proprietary Device Name:   ACCESSORIES, TRACTION CART, FRAME, CORD WEIGHT
Registered Establishment Name:  BRENNER METAL PROD CORP..
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE & ACCESSORIES
Proprietary Device Name:   ARTHROSCOPE
Registered Establishment Name:  THE MEDTECH GROUP, INC..
Classification:   PROSTHESIS, HIP, HEMI-, ACETABULAR, CEMENTED, METAL
Generic Device Name:   BUECHEL-PAPPAS ACETABULAR BEARING INSERT
Proprietary Device Name:   BUECHEL-PAPPAS ACETABULAR BEARING INSERT, FIXATION CUP
Registered Establishment Name:  ENDOTEC, INC..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BUECHEL-PAPPAS CANCELLOUS BONE SCREW
Registered Establishment Name:  ENDOTEC, INC..
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL
Generic Device Name:   BUECHEL-PAPPAS FEMORAL HEAD
Registered Establishment Name:  ENDOTEC, INC..
Classification:   PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
Generic Device Name:   BUECHEL-PAPPAS MODULAR FEMORAL STEM
Proprietary Device Name:   BUECHEL-PAPPAS MODULAR FEMORAL STEM;FEMORAL STEMS PORUS & NO
Registered Establishment Name:  ENDOTEC, INC..
Classification:   PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
Generic Device Name:   BUECHEL-PAPPAS SELF-ALIGNING ACETABULAR COMPONENT
Registered Establishment Name:  ENDOTEC, INC..
Classification:   PROSTHESIS, SHOULDER, HEMI-, GLENOID, METALLIC CEMENTED
Generic Device Name:   BUECHEL-PAPPAS GLENOID FIXATION CUP
Registered Establishment Name:  ENDOTEC, INC..
Classification:   PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
Generic Device Name:   BUECHEL-PAPPAS GLENOID BEARING
Registered Establishment Name:  ENDOTEC, INC..
Classification:   PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
Generic Device Name:   BUECHEL-PAPPAS HUMERAL STEM
Proprietary Device Name:   BUECHEL-PAPPAS HUMERAL STEM, HUMERAL HEAD
Registered Establishment Name:  ENDOTEC, INC..
Classification:   PROSTHESIS, ANKLE, CEMENTED, NON-CONSTRAINED
Generic Device Name:   BUECHEL-PAPPAS CUSTOM TOTAL ANKLE, BEARING & TALAR COMPONENT
Registered Establishment Name:  ENDOTEC, INC..
Classification:   GONIOMETER, AC-POWERED
Generic Device Name:   KNEE POSITIONING AND ALIGNMENT SYSTEM
Proprietary Device Name:   INSIGHT KNEE POSITIONING AND ALIGNMENT SYSTEM
Registered Establishment Name:  PPI-TIME ZERO INC..
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   SCOLIOMETER
Proprietary Device Name:   SCOLIOMETER
Registered Establishment Name:  DR. SABIA'S SCOLIOMETER.
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   ELEVA STRECKBANDAGE
Registered Establishment Name:  REHABILITATION TECHNICAL COMPONENTS, CORP..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   TRACTION STAND
Proprietary Device Name:   TRACTION STAND
Registered Establishment Name:  TUBULAR FABRICATORS INDUSTRY, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Generic Device Name:   VARIOUS HIP PROSTHESES, FEMORAL COMPONENT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ENCORE MEDICAL - HUNT VALLEY.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
Generic Device Name:   HIP STEM, PLASMA COATED HIP SYSTEM
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ENCORE MEDICAL - HUNT VALLEY.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT)
Generic Device Name:   HIP PROSTHESIS, ACETABULAR COMPONENT
Proprietary Device Name:   ALFA ACETABULAR CUPS WITH UHMWPE LINCERS
Registered Establishment Name:  ENCORE MEDICAL - HUNT VALLEY.
Classification:   PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Generic Device Name:   VARIOUS KNEE SYSTEMS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ENCORE MEDICAL - HUNT VALLEY.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Generic Device Name:   VARIOUS TOTAL HIP SYSTEMS, CEMENTED
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ENCORE MEDICAL - HUNT VALLEY.
Classification:   SYSTEM, CEMENT REMOVAL EXTRACTION
Generic Device Name:   BONE CEMENT EXTRACTOR
Proprietary Device Name:   IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR
Registered Establishment Name:  ENCORE MEDICAL - HUNT VALLEY.
Classification:   PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   KNEE SYSTEM
Proprietary Device Name:   MJS POSTERIOR STABILIZED KNEE SYSTEM
Registered Establishment Name:  ENCORE MEDICAL - HUNT VALLEY.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED
Generic Device Name:   CERAMIC FEMORAL HEAD SYSTEM
Proprietary Device Name:   OTI CERAMIC FEMORAL HEAD SYSTEM
Registered Establishment Name:  ENCORE MEDICAL - HUNT VALLEY.
Classification:   PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
Generic Device Name:   CERAMIC FEMORAL HEAD SYSTEM
Proprietary Device Name:   OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
Registered Establishment Name:  ENCORE MEDICAL - HUNT VALLEY.
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   ORTHOPEDIC FASTENER
Proprietary Device Name:   OTI ORTHOPEDIC FASTENER SYSTEM
Registered Establishment Name:  ENCORE MEDICAL - HUNT VALLEY.
Classification:   PROSTHESIS, HIP, FEMORAL, RESURFACING
Generic Device Name:   HIP SYSTEM COMPONENT
Proprietary Device Name:   LSF TOTAL HIP SYSTEM - BIPOLAR COMPONENT
Registered Establishment Name:  ENCORE MEDICAL - HUNT VALLEY.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
Generic Device Name:   HIP PROSTHESIS
Proprietary Device Name:   THOMPSON TYPE HIP PROSTHESIS
Registered Establishment Name:  ENCORE MEDICAL - HUNT VALLEY.
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   COMPRESSION DEVICE
Proprietary Device Name:   OTI EUROPEAN COMPRESSION SYSTEM
Registered Establishment Name:  ENCORE MEDICAL - HUNT VALLEY.
Classification:   PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
Generic Device Name:   SHOULDER PROSTHESIS SYSTEM
Proprietary Device Name:   NEER TYPE SHOULDER PROSTHESIS SYSTEM
Registered Establishment Name:  ENCORE MEDICAL - HUNT VALLEY.
Classification:   PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
Generic Device Name:   POROUS COATED FEMORAL STEMS
Proprietary Device Name:   LSF POROUS COATED FEMORAL STEMS, PRIMARY AND REVISIONS
Registered Establishment Name:  ENCORE MEDICAL - HUNT VALLEY.
Classification:   TEMPLATE
Generic Device Name:   FEMORAL TEMPLATE
Proprietary Device Name:   LSF FEMORAL TEMPLATE
Registered Establishment Name:  ENCORE MEDICAL - HUNT VALLEY.
Classification:   BROACH
Generic Device Name:   VARIOUS SIZES OF BROACHES
Proprietary Device Name:   LSF BROACH
Registered Establishment Name:  ENCORE MEDICAL - HUNT VALLEY.
Classification:   REAMER
Generic Device Name:   MULTIPLE ORTHOPEDIC REAMERS
Proprietary Device Name:   ORTHOPEDIC REAMER
Registered Establishment Name:  ENCORE MEDICAL - HUNT VALLEY.
Classification:   PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
Generic Device Name:   VARIOUS TYPES & SIZES OF MODULAR & NON-MODULAR HUMERAL COMPONENTS W/HUMERAL
Proprietary Device Name:   OTI SHOULDER SYSTEM
Registered Establishment Name:  ENCORE MEDICAL - HUNT VALLEY.
Classification:   PROSTHESIS, KNEE, HEMI-, TIBIAL, RESURFACING (UNCEMENTED)
Generic Device Name:   UNICONDULAR INTERPOSITIONAL SPACER
Proprietary Device Name:   OTI UNICONDULAR INTERPOSITIONAL SPACER
Registered Establishment Name:  ENCORE MEDICAL - HUNT VALLEY.

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Last Modified: 29 April 2006
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