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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:   SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Generic Device Name:   VARIOUS SIZES OF VERTEBRAL BODY REPLACEMENT, VBR DEVICES
Proprietary Device Name:   ENDOSKELETON VERTEBRAL BODY REPLACEMENT
Registered Establishment Name:  ORTHOVITA, INC..
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   VARIOUS SIZES AND SHAPES OF STERILE BONE GRAFT MATERIAL
Proprietary Device Name:   VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL, VITOSS SCAFFOLD CANCELLOUS BONE VOID F
Registered Establishment Name:  ORTHOVITA, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   OPERATING SCISSORS
Proprietary Device Name:   SCISSORS OPERATING
Registered Establishment Name:  GALA OVERSEAS CORP..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   OPERATING SCISSORS
Proprietary Device Name:   SCISSORS OPERATING
Registered Establishment Name:  FORGER INSTRUMENTS CO..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  SUNLIKE INDUSTRIES.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   WIRE DRIVER
Proprietary Device Name:   S & S WIRE DRIVER 701
Registered Establishment Name:  S & S ORTHOPEDIC LTD..
Classification:   PUMP, VACUUM, ELECTRIC, SUCTION-TYPE ELECTRODE
Generic Device Name:   SPINE FIXATION SYSTEM
Proprietary Device Name:   J.B.S. SPINE SYSTEM
Registered Establishment Name:  J.B.S., S.A..
Classification:   PROSTHESIS, KNEE, HEMI-, FEMORAL
Generic Device Name:   PARTIAL KNEE PROSTHESIS
Proprietary Device Name:   J.B.S. TROCHLEOR
Registered Establishment Name:  J.B.S., S.A..
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   CERVICAL SPINE FIXATION SYSTEM
Proprietary Device Name:   J.B.S. CERVICAL SPINE SYSTEM
Registered Establishment Name:  J.B.S., S.A..
Classification:   PROSTHESIS, INTERVERTEBRAL DISC
Generic Device Name:   INTERVERTEBRAL DISC PROTHESIS
Proprietary Device Name:   J.B.S. PRODISC INTERVERTEBRAL DISC PROSTHESIS
Registered Establishment Name:  J.B.S., S.A..
Classification:   IMPLANT, FIXATION DEVICE, SPINAL
Generic Device Name:   IMPLANTABLE SPINAL FIXATION DEVICE
Proprietary Device Name:   J.B.S. SPINE SYSTEM
Registered Establishment Name:  J.B.S., S.A..
Classification:   AWL
Generic Device Name:   AWL
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  J.B.S., S.A..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BONE SCREW
Proprietary Device Name:   J.B.S. BONE SCREW
Registered Establishment Name:  J.B.S., S.A..
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   THREADED FIXATION PIN
Proprietary Device Name:   J.B.S. SELF-TRAPPING THREADED PIN
Registered Establishment Name:  J.B.S., S.A..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  J.B.S., S.A..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   BONE PLATE
Proprietary Device Name:   J.B.S. BONE PLATE
Registered Establishment Name:  J.B.S., S.A..
Classification:   SCREWDRIVER
Generic Device Name:   SCREWDRIVER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  J.B.S., S.A..
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   SPINAL FIXATION ROD
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  J.B.S., S.A..
Classification:   BENDER
Generic Device Name:   MULTIPLE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  J.B.S., S.A..
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   SMOOTH SELF-BREAKING FIXATION PIN
Proprietary Device Name:   J.B.S. B.A.C. PIN
Registered Establishment Name:  J.B.S., S.A..
Classification:   TWISTER, WIRE
Generic Device Name:   WIRE HOLDING CLAMP,VARIOUS SIZES
Proprietary Device Name:   WIRE HOLDING CLAMP,VARIOUS SIZES
Registered Establishment Name:  RZ MEDIZINTECHNIK GMBH.
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE SHEATH
Proprietary Device Name:   ARTHROSCOPE AND ACCESSORIES
Registered Establishment Name:  RZ MEDIZINTECHNIK GMBH.
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   MENISCOTOME,VARIOUS SIZES
Proprietary Device Name:   MENISCOTOME,VARIOUS SIZES
Registered Establishment Name:  RZ MEDIZINTECHNIK GMBH.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSOR, VARIOUS SIZES
Proprietary Device Name:   SCISSOR, VARIOUS SIZES
Registered Establishment Name:  RZ MEDIZINTECHNIK GMBH.
Classification:   SCREWDRIVER
Generic Device Name:   SCREWDRIVER
Proprietary Device Name:   SCREWDRIVER
Registered Establishment Name:  RZ MEDIZINTECHNIK GMBH.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   SCREW, FIXATION, BONE
Proprietary Device Name:   SCREW, FIXATION, BONE
Registered Establishment Name:  RZ MEDIZINTECHNIK GMBH.
Classification:   BRACE, DRILL
Generic Device Name:   DRILL
Proprietary Device Name:   DRILL
Registered Establishment Name:  RZ MEDIZINTECHNIK GMBH.
Classification:   RONGEUR
Generic Device Name:   RONGEUR VARIOUS TYPES AND SIZES
Proprietary Device Name:   RONGEUR VARIOUS TYPES AND SIZES
Registered Establishment Name:  RZ MEDIZINTECHNIK GMBH.
Classification:   CUTTER, WIRE
Generic Device Name:   ORTHOPEDIC WIRE CUTTER
Proprietary Device Name:   ORTHOPEDIC WIRE CUTTER
Registered Establishment Name:  SURGIMED U.K..
Classification:   STARTER, BONE SCREW
Generic Device Name:   HARKI BONE REMOVAL INSTRUMENT
Proprietary Device Name:   HARKI BONE REMOVAL INSTRUMENT
Registered Establishment Name:  JOINT-JACK CO..
Classification:   SET, HOLLOW MILL
Generic Device Name:   MILL (VARIOUS)
Proprietary Device Name:   RFQ-MEDIZINTECHNIK GMBH & CO. KG
Registered Establishment Name:  RFQ-MEDIZINTECHNIK GMBH & CO. KG.
Classification:   ACCESSORIES,ARTHROSCOPIC
Generic Device Name:   ARTHROSCOPIC ACCESSORIES
Proprietary Device Name:   RFQ-MEDIZINTECHNIK GMBH & CO. KG
Registered Establishment Name:  RFQ-MEDIZINTECHNIK GMBH & CO. KG.
Classification:   BONE MILL
Generic Device Name:   BONE MILL
Proprietary Device Name:   RFQ-MEDIZINTECHNIK GMBH & CO. KG
Registered Establishment Name:  RFQ-MEDIZINTECHNIK GMBH & CO. KG.
Classification:   CUTTER, WIRE
Generic Device Name:   WIRE CUTTER
Proprietary Device Name:   RFQ-MEDIZINTECHNIK GMBH & CO. KG
Registered Establishment Name:  RFQ-MEDIZINTECHNIK GMBH & CO. KG.
Classification:   WIRE, SURGICAL
Generic Device Name:   WIRE (VARIOUS)
Proprietary Device Name:   RFQ-MEDIZINTECHNIK GMBH & CO. KG
Registered Establishment Name:  RFQ-MEDIZINTECHNIK GMBH & CO. KG.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC INSTRUMENT (VARIOUS)
Proprietary Device Name:   RFQ-MEDIZINTECHNIK GMBH & CO. KG
Registered Establishment Name:  RFQ-MEDIZINTECHNIK GMBH & CO. KG.
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   BURR (VARIOUS)
Proprietary Device Name:   RFQ-MEDIZINTECHNIK GMBH & CO. KG
Registered Establishment Name:  RFQ-MEDIZINTECHNIK GMBH & CO. KG.
Classification:   INSTRUMENT, CAST REMOVAL, AC-POWERED
Generic Device Name:   SAW (VARIOUS)
Proprietary Device Name:   RFQ-MEDIZINTECHNIK GMBH & CO. KG
Registered Establishment Name:  RFQ-MEDIZINTECHNIK GMBH & CO. KG.
Classification:   PROBE
Generic Device Name:   PROBE (VARIOUS)
Proprietary Device Name:   PROBE
Registered Establishment Name:  TRIAD PRODUCTS CORP..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC HAND INSTRUMENTS
Proprietary Device Name:   VARIOUS TYPES OF ORTHOPEDIC HAND INSTRUMENTS
Registered Establishment Name:  HERMANN MUELLER INH. GEBHARD MUELLER.

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Last Modified: 29 April 2006
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