 |
|||||||
US Food and Drug Administration (FDA) - Orthopedic Devices Registration |
|||||||
|
|||||||
|
|
|||||||
US Food and Drug Administration (FDA) - Orthopedic Devices Registration |
|||||||
|
|||||||
| First Page | Previous Page | Next Page | Last Page |
|
Classification: ORTHOSIS, SPINAL PEDICLE FIXATION Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: TECHRON AG. |
|
Classification: PIN, FIXATION, THREADED Generic Device Name: SCHANZ SCREW, ETC. Proprietary Device Name: VARIOUS Registered Establishment Name: TECHRON AG. |
|
Classification: PLATE, FIXATION, BONE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: TECHRON AG. |
|
Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Generic Device Name: VARIOUS TYPES AND SIZES OF PLATE AND SCREW, ETC. COMBINATION DEVICES Proprietary Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Registered Establishment Name: TECHRON AG. |
|
Classification: ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION Generic Device Name: VARIOUS TYPES AND SIZES OF SPONDYLOLISTHESIS SPINAL FIXATION ORTHOSES Proprietary Device Name: MULTIPLE Registered Establishment Name: TECHRON AG. |
|
Classification: APPLIANCE, FIXATION, SPINAL INTERLAMINAL Generic Device Name: VARIOUS TYPES AND SIZES OF SPINAL INTERVERTEBRAL BODY FIXATION APPLIANCES Proprietary Device Name: MULTIPLE Registered Establishment Name: TECHRON AG. |
|
Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE Generic Device Name: VARIOUS TYPES AND SIZES OF NAIL/BLADE/PLATE COMBINATION FIXATION APPLIANCES Proprietary Device Name: MULTIPLE Registered Establishment Name: TECHRON AG. |
|
Classification: NAIL, FIXATION, BONE Generic Device Name: VARIOUS TYPES AND SIZES OF BONE FIXATION NAILS Proprietary Device Name: MULTIPLE Registered Establishment Name: TECHRON AG. |
|
Classification: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Generic Device Name: VARIOUS TYPES AND SIZES OF INTRAMEDULLARY NAILS AND ACCESSORIES Proprietary Device Name: MULTIPLE Registered Establishment Name: TECHRON AG. |
|
Classification: PIN, FIXATION, SMOOTH Generic Device Name: VARIOUS TYPES AND SIZES OF SMOOTH FIXATION PINS Proprietary Device Name: MULTIPLE Registered Establishment Name: TECHRON AG. |
|
Classification: COMPONENT, TRACTION, NON-INVASIVE Generic Device Name: NONINVASIVE TRACTION COMPONENT Proprietary Device Name: MULTIPLE Registered Establishment Name: PHASE II MEDICAL MANUFACTURING, INC.. |
|
Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: TRACTION SET Proprietary Device Name: TRACTION SET Registered Establishment Name: NAN HSING PIONEER CO., LTD.. |
|
Classification: ARTHROSCOPE Generic Device Name: DRILL SLEEVE CAPS, DRILLS, OBTURATORS, SIZERS, HANDLE, RULER, DRILL SLEEVES, STE Proprietary Device Name: OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM Registered Establishment Name: OSTEOBIOLOGICS, INC.. |
|
Classification: KNIFE, ORTHOPEDIC Generic Device Name: KNIFE Proprietary Device Name: TRIMMING TOOL Registered Establishment Name: OSTEOBIOLOGICS, INC.. |
|
Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: IMPLANT LOADER Proprietary Device Name: DELIVERY DEVICE Registered Establishment Name: OSTEOBIOLOGICS, INC.. |
|
Classification: BIT, DRILL Generic Device Name: HAND DRILL Proprietary Device Name: TRUKOR (TM) HAND DRILL Registered Establishment Name: OSTEOBIOLOGICS, INC.. |
|
Classification: FILLER, BONE VOID, CALCIUM COMPOUND Generic Device Name: RESORBABLE BONE VOID FILLER Proprietary Device Name: POLYGRAFT BGS Registered Establishment Name: OSTEOBIOLOGICS, INC.. |
|
Classification: IMPACTOR Generic Device Name: DRILL SLEEVE CAP Proprietary Device Name: TRUKOR DRILL SLEEVE CAP Registered Establishment Name: OSTEOBIOLOGICS, INC.. |
|
Classification: GONIOMETER, AC-POWERED Generic Device Name: MOTION DETECTOR Proprietary Device Name: OSSUR PAM Registered Establishment Name: OSSUR H/F. |
|
Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Proprietary Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Registered Establishment Name: NEW ENGLAND MEDICAL CORP.. |
|
Classification: DYNAMOMETER, NONPOWERED Generic Device Name: DYNAMOMETER, NONPOWERED Proprietary Device Name: DYNAMOMETER, NONPOWERED Registered Establishment Name: NEW ENGLAND MEDICAL CORP.. |
|
Classification: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Generic Device Name: SEMI-CONSTRAINED TOTAL KNEE SYSTEM Proprietary Device Name: GENUFITT TOTAL KNEE SYSTEM Registered Establishment Name: LAFITT. |
|
Classification: BIT, DRILL Generic Device Name: VARIOUS SIZES OF DRILL BITS Proprietary Device Name: BIT, DRILL Registered Establishment Name: BHH HUTA BAILDON. |
|
Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: DISTRACTION PIN, VARIOUS SIZES Proprietary Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Registered Establishment Name: BHH HUTA BAILDON. |
|
Classification: PIN, FIXATION, SMOOTH Generic Device Name: TROCAR PIN Proprietary Device Name: PIN, FIXATION, SMOOTH Registered Establishment Name: BHH HUTA BAILDON. |
|
Classification: PIN, FIXATION, SMOOTH Generic Device Name: K-WIRE Proprietary Device Name: PIN, FIXATION, SMOOTH Registered Establishment Name: BEZNOSKA S.R.O.. |
|
Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS TYPES OF ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS Proprietary Device Name: MULTIPLE BRANDS OF ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS Registered Establishment Name: BEZNOSKA S.R.O.. |
|
Classification: RONGEUR Generic Device Name: RONGEUR Proprietary Device Name: RONGEUR Registered Establishment Name: BEZNOSKA S.R.O.. |
|
Classification: GAUGE, DEPTH Generic Device Name: GAUGE, DEPTH Proprietary Device Name: GAUGE, DEPTH (MULTIPLE BRANDS) Registered Establishment Name: BEZNOSKA S.R.O.. |
|
Classification: WRENCH Generic Device Name: WRENCH Proprietary Device Name: WRENCH (MULTIPLE BRANDS) Registered Establishment Name: BEZNOSKA S.R.O.. |
|
Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: MULTIPLE Proprietary Device Name: MULTIPLE Registered Establishment Name: XAVIER ENT.. |
|
Classification: DISPENSER, CEMENT Generic Device Name: BONE CEMENT DELIVERY Proprietary Device Name: MULTIPLE Registered Establishment Name: SUMMIT MEDICAL LTD.. |
|
Classification: MIXER, CEMENT, FOR CLINICAL USE Generic Device Name: BONE CEMENT MIXER Proprietary Device Name: MULTIPLE Registered Establishment Name: SUMMIT MEDICAL LTD.. |
|
Classification: PROSTHESIS, WRIST, CARPAL LUNATE Generic Device Name: WRIST BRACE Proprietary Device Name: SOF*BRACE Registered Establishment Name: BETTER HANDS GLOVE PRODUCTS. |
|
Classification: PROSTHESIS, FINGER, CONSTRAINED, POLYMER Generic Device Name: VARIOUS TYPES Proprietary Device Name: MULTIPLE Registered Establishment Name: NEXA ORTHOPEDICS, INC.. |
|
Classification: PROSTHESIS, TOE, CONSTRAINED, POLYMER Generic Device Name: VARIOUS SIZES OF STERILE TOE JOINT IMPLANTS Proprietary Device Name: FLEXIBLE DIGITAL PROSTHESIS Registered Establishment Name: NEXA ORTHOPEDICS, INC.. |
|
Classification: PROSTHESIS, TOE, HEMI-, PHALANGEAL Generic Device Name: VARIOUS STYLES & SIZES Proprietary Device Name: HEMI GREAT TOE REPLACEMENT PROSTHESIS Registered Establishment Name: NEXA ORTHOPEDICS, INC.. |
|
Classification: PROSTHESIS, TOE (METATARSOPHALANGEAL), JOINT, METAL/POLYMER, SEMI-CONSTRAINED Generic Device Name: VARIOUS STYLES & SIZES Proprietary Device Name: HINGED GREAT TOE REPLACEMENT PROSTHESIS Registered Establishment Name: NEXA ORTHOPEDICS, INC.. |
|
Classification: PIN, FIXATION, SMOOTH, METALLIC Generic Device Name: SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER Proprietary Device Name: SUBTALAR ARTHROSIS IMPLANT Registered Establishment Name: NEXA ORTHOPEDICS, INC.. |
|
Classification: PLATE, FIXATION, BONE Generic Device Name: UBP SYSTEM Proprietary Device Name: UNIVERSAL BONE PLATE SYSTEM Registered Establishment Name: ABBOTT SPINE, INC.. |
| First Page | Previous Page | Next Page | Last Page |
