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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:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   INTRAMEDULLARY FEMORAL NAIL
Proprietary Device Name:   AOS MODULAR FEMORAL NAIL
Registered Establishment Name:  ADVANCED ORTHOPAEDIC SOLUTIONS, INC..
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES, METALLIC AND NON-COLLAPSIBLE
Generic Device Name:   INTRAMEDULLARY FEMORAL NAIL
Proprietary Device Name:   AOS MODULAR FEMORAL NAIL
Registered Establishment Name:  ADVANCED ORTHOPAEDIC SOLUTIONS, INC..
Classification:   SCREW, FIXATION, BONE, NON-SPINAL, METALLIC
Generic Device Name:   BONE SCREW
Proprietary Device Name:   BONE SCREW
Registered Establishment Name:  ADVANCED ORTHOPAEDIC SOLUTIONS, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ADVANCED ORTHOPAEDIC SOLUTIONS, INC..
Classification:   RONGEUR
Generic Device Name:   RONGEUR (VARIOUS TYPES AND SIZES)
Proprietary Device Name:   RONGEUR (MULTIPLE BRANDS)
Registered Establishment Name:  ULTIMATE MEDICAL PRODUCTS LTD..
Classification:   POSITIONER, SOCKET
Generic Device Name:   POSITIONER
Proprietary Device Name:   TRI-MEDICS, INC BENDER TRIANGLE
Registered Establishment Name:  TRI-MEDICS, INC..
Classification:   COMPONENT, TRACTION, NON-INVASIVE
Generic Device Name:   SLISHMAN SPLINT
Proprietary Device Name:   SLISHMAN SPLINT
Registered Establishment Name:  SLISHMAN SPLINT.
Classification:   DYNAMOMETER, AC-POWERED
Generic Device Name:   FORCE MEASUREMENT DEVICE
Proprietary Device Name:   KADANCE HAND SENSOR SYSTEM
Registered Establishment Name:  KADA RESEARCH, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  MEDETRADE INTL..
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   BONE GRAFT SUBSTITURE
Proprietary Device Name:   HEALOS R BONE GRAFT MATERIAL
Registered Establishment Name:  DEPUY SPINE, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   DURA CORP.
Registered Establishment Name:  DURA CORP..
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
Generic Device Name:   AUSTIN MOORE/THOMPSON/SELF LOCKIN/APSIS
Proprietary Device Name:   HIP PROSTHESIS
Registered Establishment Name:  TRAIBER, S.A..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT)
Generic Device Name:   ACETABULAR CUPS/ XALOC
Proprietary Device Name:   ACETABULAR
Registered Establishment Name:  TRAIBER, S.A..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   CORTICAL SCREWS / CANCELLOUS SCREWS
Proprietary Device Name:   CORTICAL SCREWS / CANCELLOUS SCREWS
Registered Establishment Name:  TRAIBER, S.A..
Classification:   IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
Generic Device Name:   CONDYLAR PLATE
Proprietary Device Name:   CONDYLAR PLATE
Registered Establishment Name:  TRAIBER, S.A..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   MINI FRAGMENT BONE PLATE
Proprietary Device Name:   MINI FRAGMENT BONE PLATE
Registered Establishment Name:  TRAIBER, S.A..
Classification:   PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   EXCEL
Proprietary Device Name:   KNEE PROSTHESIS
Registered Establishment Name:  TRAIBER, S.A..
Classification:   COMPONENT, CAST
Generic Device Name:   CASTWEDGE
Proprietary Device Name:   CASTWEDGE
Registered Establishment Name:  DM SYSTEMS, INCORPORATED.
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   UNIVERSAL CASTING STAND
Proprietary Device Name:   UNIVERSAL CASTING STAND
Registered Establishment Name:  CUSTOM MACHINE & TOOLING.
Classification:   COMPONENT, CAST
Generic Device Name:   PARCHE POROSO
Proprietary Device Name:   GUADALUPANO PARJHE POROO
Registered Establishment Name:  QUIMICA Y FARMACIA S.A. DE C.V..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   SUTURE PASSING DEVICE
Proprietary Device Name:   SUTURING SOLUTION
Registered Establishment Name:  SURGICAL SOLUTIONS, LLC..
Classification:   BIT, DRILL
Generic Device Name:   DRILL BIT
Proprietary Device Name:   DRILL BIT
Registered Establishment Name:  MEDICREA.
Classification:   SCREWDRIVER
Generic Device Name:   SCREWDRIVER
Proprietary Device Name:   SCREWDRIVER
Registered Establishment Name:  MEDICREA.
Classification:   GAUGE, DEPTH
Generic Device Name:   GAUGE, DEPTH
Proprietary Device Name:   GAUGE, DEPTH
Registered Establishment Name:  MEDICREA.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Registered Establishment Name:  MEDICREA.
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   PEDICLE SCREW SYSTEM
Proprietary Device Name:   PASS
Registered Establishment Name:  MEDICREA.
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   PEDICLES SCREW SYSTEM
Proprietary Device Name:   PASS
Registered Establishment Name:  MEDICREA.
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   POSTERIOR SPINE SYSTEM
Proprietary Device Name:   PASS
Registered Establishment Name:  MEDICREA.
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   BONE VOID FILLER
Proprietary Device Name:   OSMOSYS BONE VOID FILLER
Registered Establishment Name:  MEDICREA.
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   BURR CHANGER
Proprietary Device Name:   BURR
Registered Establishment Name:  ZAIN'S MEDICAL IMAGE.
Classification:   BIT, DRILL
Generic Device Name:   DRILL BIT
Proprietary Device Name:   DRILL BIT
Registered Establishment Name:  ZAIN'S MEDICAL IMAGE.
Classification:   DRIVER, PROSTHESIS
Generic Device Name:   VARIOUS TYPES OF DRIVERS
Proprietary Device Name:   DRIVER, PROSTHESIS (MULTIPLE BRANDS)
Registered Establishment Name:  SPINEVISION, S.A..
Classification:   TEMPLATE
Generic Device Name:   VARIOUS TYPES OF TEMPLATES
Proprietary Device Name:   TEMPLATE (MULTIPLE BRANDS)
Registered Establishment Name:  SPINEVISION, S.A..
Classification:   GAUGE, DEPTH
Generic Device Name:   VARIOUS TYPES OF DEPTH GAUGE
Proprietary Device Name:   GAUGE, DEPTH (MULTIPLE BRANDS)
Registered Establishment Name:  SPINEVISION, S.A..
Classification:   WRENCH
Generic Device Name:   VARIOUS TYPES OF WRENCH
Proprietary Device Name:   WRENCH (MULTIPLE BRANDS)
Registered Establishment Name:  SPINEVISION, S.A..
Classification:   PROBE
Generic Device Name:   VARIOUS TYPES OF PROBE
Proprietary Device Name:   PROBE (MULTIPLE BRANDS)
Registered Establishment Name:  SPINEVISION, S.A..
Classification:   TREPHINE
Generic Device Name:   VARIOUS TYPES OF TREPHINE
Proprietary Device Name:   TREPHINE (MULTIPLE BRANDS)
Registered Establishment Name:  SPINEVISION, S.A..
Classification:   AWL
Generic Device Name:   VARIOUS TYPES OF AWL
Proprietary Device Name:   AWL (MULTIPLE BRANDS)
Registered Establishment Name:  SPINEVISION, S.A..
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS TYPES OF DRILL BITS
Proprietary Device Name:   BIT, DRILL (MULTIPLE BRANDS)
Registered Establishment Name:  SPINEVISION, S.A..
Classification:   TAP, BONE
Generic Device Name:   VARIOUS TYPES OF BONE TAP
Proprietary Device Name:   TAP, BONE (MULTIPLE BRANDS)
Registered Establishment Name:  SPINEVISION, S.A..

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Last Modified: 29 April 2006
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