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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:   SCREWDRIVER
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  PRO-MED INSTRUMENTE GMBH.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS, ORTHOPAEDIC
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  WM INSTRUMENTE GMBH.
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  WM INSTRUMENTE GMBH.
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   KNIFE, ORTHOPAEDIC
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  WM INSTRUMENTE GMBH.
Classification:   BIT, DRILL
Generic Device Name:   BIT, DRILL
Proprietary Device Name:   BIT, DRILL
Registered Establishment Name:  JAKOUBEK GMBH.
Classification:   GAUGE, DEPTH
Generic Device Name:   VARIOUS TYPES OF DEPTH GAUGES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  JAKOUBEK GMBH.
Classification:   PUNCH, FEMORAL NECK
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC PUNCHES
Proprietary Device Name:   MULTIPLE BRANDS OF ORTHOPEDIC PUNCHES
Registered Establishment Name:  JAKOUBEK GMBH.
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEURS
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  MANFRED HEINEMANN.
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RANGEURS, ORTHOPEDIC
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  KAPP SURGICAL GMBH.
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS TYPES OF CUTTERS, WIRES, ORTHOPEDIC
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  KAPP SURGICAL GMBH.
Classification:   IMPLANT, FIXATION DEVICE, SPINAL
Generic Device Name:   MULTIPLE,ZIELKE VDS,USIS,SLOT ZIELKE
Proprietary Device Name:   MULTIPLE,ZIELKE VDS,USIS,SLOT ZIELKE
Registered Establishment Name:  ULRICH GMBH & CO. KG.
Classification:   SCREWDRIVER
Generic Device Name:   RATEHET SCREWDRIVER,STRAIGHT SCREWDRIVER,CARDAN
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ULRICH GMBH & CO. KG.
Classification:   INSTRUMENT, BENDING OR CONTOURING
Generic Device Name:   ZIELKE DEROTATOR
Proprietary Device Name:   ZIELKE DEROTATOR
Registered Establishment Name:  ULRICH GMBH & CO. KG.
Classification:   IMPACTOR
Generic Device Name:   IMPACTOR, VARIOUS TYPES
Proprietary Device Name:   ULRICH IMPACTOR, HARMS IMPACTOR
Registered Establishment Name:  ULRICH GMBH & CO. KG.
Classification:   AWL
Generic Device Name:   VARIOUS TYPES OF AWLS
Proprietary Device Name:   ULRICH AWL
Registered Establishment Name:  ULRICH GMBH & CO. KG.
Classification:   WRENCH
Generic Device Name:   VARIOUS TYPES OF WRENCHES
Proprietary Device Name:   ULRICH WRENCH
Registered Establishment Name:  ULRICH GMBH & CO. KG.
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   ORTHOPEDIC GONIOMETER (MECHANICAL)
Proprietary Device Name:   ULRICH GONIOMETER
Registered Establishment Name:  ULRICH GMBH & CO. KG.
Classification:   INSTRUMENT, COMPRESSION
Generic Device Name:   COMPRESSION/DISTRACTION INSTRUMENT
Proprietary Device Name:   ULRICH COMPRESSION/DISTRACTION DEVICE
Registered Establishment Name:  ULRICH GMBH & CO. KG.
Classification:   TAP, BONE
Generic Device Name:   BONE TAP
Proprietary Device Name:   ULRICH BONE TAP
Registered Establishment Name:  ULRICH GMBH & CO. KG.
Classification:   GAUGE, DEPTH
Generic Device Name:   DEPTH GAUGE
Proprietary Device Name:   ULRICH DEPTH GAUGE
Registered Establishment Name:  ULRICH GMBH & CO. KG.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   ULRICH USIS PROBE
Registered Establishment Name:  ULRICH GMBH & CO. KG.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS, VARIOUS TYPES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ULRICH GMBH & CO. KG.
Classification:   TWISTER, WIRE
Generic Device Name:   WIRE TWISTER
Proprietary Device Name:   ULRICH JET TWISTER
Registered Establishment Name:  ULRICH GMBH & CO. KG.
Classification:   RONGEUR
Generic Device Name:   RONGEUR, VARIOUS TYPES
Proprietary Device Name:   ZIELKE RONGEUR, ULRICH
Registered Establishment Name:  ULRICH GMBH & CO. KG.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   ULRICH SCISSORS
Registered Establishment Name:  ULRICH GMBH & CO. KG.
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   POSTERIOR SPINAL FIXATION DEVICE
Proprietary Device Name:   SEGMENTAL SPINAL CORRECTION SYSTEM (SSCS)
Registered Establishment Name:  ULRICH GMBH & CO. KG.
Classification:   SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Generic Device Name:   VERTEBRAL BODY REPLACEMENT DEVICE
Proprietary Device Name:   VBR
Registered Establishment Name:  ULRICH GMBH & CO. KG.
Classification:   STRIPPER, SURGICAL
Generic Device Name:   VARIOUS TYPES OF SURGICAL STRIPPERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ULRICH GMBH & CO. KG.
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS TYPES OF DRILL BITS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ULRICH GMBH & CO. KG.
Classification:   SET, HOLLOW MILL
Generic Device Name:   VARIOUS TYPES OF MILLS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ULRICH GMBH & CO. KG.
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Generic Device Name:   SPINAL IMPLANT SYSTEM
Proprietary Device Name:   TANGORS POLYAXIAL SYSTEM
Registered Establishment Name:  ULRICH GMBH & CO. KG.
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   SPINAL IMPLANT SYSTEM
Proprietary Device Name:   TANGORS POLYAXIAL SYSTEM
Registered Establishment Name:  ULRICH GMBH & CO. KG.
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   SPINAL IMPLANT SYSTEM
Proprietary Device Name:   TANGORS POLYAXIAL SYSTEM
Registered Establishment Name:  ULRICH GMBH & CO. KG.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  MUELLER-INSTRUMENTE INH. HENRIKE MUELLER.
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPES AND MINI ARTHROSCOPES AND ACCESSORIES
Proprietary Device Name:   ARTHROSCOPES AND MINI ARTHROSCOPES AND ACCESSORIES
Registered Establishment Name:  COMEG ENDOSKOPIE GMBH.
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   SAME
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  A. HENNISS.
Classification:   BIT, DRILL
Generic Device Name:   SAME
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  A. HENNISS.
Classification:   RONGEUR
Generic Device Name:   LISTON-STILLE BONE CUTTING FORCEPS
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  A. HENNISS.
Classification:   TWISTER, WIRE
Generic Device Name:   SAME
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  A. HENNISS.
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   SAME, ALL TYPES AND SIZES
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  A. HENNISS.

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Last Modified: 29 April 2006
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