meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
27
Latest Decision
1997-07-16

Clearances · page 136 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K971414 ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS Smith & Nephew, Inc., Orthopaedic Div. LZO Class II 1997-07-16
K971435 HEADLOC CERAMIC FEMORAL HEADS Ortho Development Corp. LZO Class II 1997-07-09
K971321 OSTEO COMPRESSION CONDYLE SCREW SYSTEM Osteonics Corp. HRS Class II 1997-07-09
K971409 OSTEONICS ALUMINA C-TAPER HEAD Osteonics Corp. LZO Class II 1997-07-09
K971332 AMS MAINSTAY UROLOGIC BONE ANCHOR American Medical Systems, Inc. MBI Class II 1997-07-09
K971654 OSTEO COMPRESSION HIP SCREW SYSTEM Osteonics Corp. HWC Class II 1997-07-09
K971069 TWIST-OFF (TM) SCREW Landos, Inc. HWC Class II 1997-07-09
K971070 SCARF THREAD-HEAD (TM) HEAD SCREW Landos, Inc. HWC Class II 1997-07-09
K971426 HEADLOC CERAMIC HEAD Ortho Development Corp. LZO Class II 1997-07-09
K971429 INTERSEAL ACETABULAR SCREW HOLE PLUG Wrightmedicaltechnologyinc LPH Class II 1997-07-09
K971068 34MM SCARF THREAD-HEAD(TM) SCREW Landos, Inc. HWC Class II 1997-07-09
K971358 BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM Arthrex, Inc. MAI Class II 1997-07-09
K971079 INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE Interlogics, Inc. KQX Class I 1997-07-09
K971550 KINEMATIC ALL-POLYETHYLENE PATELLA WITH THREE PEGS Howmedica Corp. JWH Class II 1997-07-08
K961732 KAR Landos, Inc. MEH Class II 1997-07-08
K970300 NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI Intermedics Orthopedics LPH Class II 1997-07-03
K971676 LIMITED REUSE ENDOSCOPIC BLADES Smith & Nephew, Inc. HRX Class II 1997-06-27
K965002 ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND Encore Orthopedics, Inc. LZO Class II 1997-06-27
K971282 ANCHORLOK AND ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM Wrightmedicaltechnologyinc MBI Class II 1997-06-27
K971682 J-FX CERCLAGE SYSTEM Johnson & Johnson Professionals, Inc. LRN Class II 1997-06-27
K971778 OSTEO SMALL AND MINI BONE SCREWS Osteonics Corp. HWC Class II 1997-06-27
K970285 AESUCLAP SOCON SPINAL SYSTEM Aesculap, Inc. MNH Class II 1997-06-25
K971139 BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT Boston Scientific Corp MBI Class II 1997-06-25
K971144 MULTITAK SS SUTURE SYSTEM Bonutti Research MBI Class II 1997-06-25
K971453 ORTHOTEC K-CAP SYSTEM Orthotech HTY Class II 1997-06-24
K971083 ARTHROSCOPE Electro-Biology, Inc. HRX Class II 1997-06-23
K971047 FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT Nexa Orthopedics, Inc. KWD Class II 1997-06-20
K963932 PRELOADED SOFT TISSUE ANCHOR Linvatec Corp. MBI Class II 1997-06-20
K964650 TCP-COATED POROCOAT AML FEMORAL HIP PROSTHESIS Depuy, Inc. LPH Class II 1997-06-19
K964509 IMPLEX A-240 HEP ACETABULAR CUP SYSTEM Implex Corp. LPH Class II 1997-06-19
K971289 SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) Osteotech, Inc. KWP Class II 1997-06-18
K971020 LSF TRIAD TOTAL HIP SYSTEM Osteoimplant Technology, Inc. LPH Class II 1997-06-18
K971059 UNIVERSAL DRIVE SYSTEM Linvatec Corp. HRX Class II 1997-06-18
K971253 VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS Smith & Nephew, Inc. HRX Class II 1997-06-13
K971248 KANEDA SR ANTERIOR SPINAL SYSTEM Acromed Corp. KWQ Class II 1997-06-11
K970955 ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM Acromed Corp. KWQ Class II 1997-06-11
K965173 DURATION STABILIZED UHMWPE KNEE COMPONENTS Howmedica Corp. JWH Class II 1997-06-11
K963612 DURATION STABILIZED UHMWPE Howmedica Corp. JDI Class II 1997-06-11
K970896 MITEK 3.5 MM PANALOK WEDGE ABSORBABLE SUTURE ANCHOR SYSTEM ETHICON, Inc. MAI Class II 1997-06-09
K964805 BIO-ANCHOR Linvatec Corp. MAI Class II 1997-06-09
K970929 DEPUY LOW PROFILE BONE SCREW Depuy, Inc. HWC Class II 1997-06-09
K970846 22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD Landos, Inc. LZO Class II 1997-06-05
K971135 MAGELLAN INTRAMEDULLARY FEMORAL NAIL SYSTEM Wrightmedicaltechnologyinc HSB Class II 1997-06-05
K971272 TRAUMA-FIX EXTERNAL FIXATOR Trend Medical, Inc. KTW Class II 1997-06-05
K965204 AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT Avanta Orthopaedics, Inc. KYI Class II 1997-06-03
K970950 EASY ROD Acromed Corp. MNH Class II 1997-06-03
K970758 DURACON EXTRA-SMALL STABILIZER TIBIAL INSERT & BASEPLATE Howmedica Corp. JWH Class II 1997-05-22
K970257 FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES Ferguson Medical HSB Class II 1997-05-22
K970706 INTER-OP POROUS PROTRUSIO SHELL WITH SEALABLE SCREWHOLES Sulzer Orthopedics, Inc. LPH Class II 1997-05-22
K970280 FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF PER-TROCHANTEROAM FRACTURES Ferguson Medical HSB Class II 1997-05-22
K970705 INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES Sulzer Orthopedics, Inc. LPH Class II 1997-05-22
K970258 FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMORAL NECK FRACTURES Ferguson Medical HRS Class II 1997-05-22
K963369 BIO-ANCHOR Linvatec Corp. MAI Class II 1997-05-22
K971422 OSTEONICS ACETABULAR WEDGE SYSTEM Osteonics Corp. MEH Class II 1997-05-22
K970642 TENOSCOPE Luxtec Corp. HRX Class II 1997-05-21
K970562 TENOSNARE Luxtec Corp. HRX Class II 1997-05-14
K970748 TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM Smith & Nephew, Inc., Orthopaedic Div. KTT Class II 1997-05-09
K961608 SYNTHES (U.S.A.) POLYPIN Synthes (Usa) HTY Class II 1997-05-09
K965224 EMPOWER ANTERIOR DIRECT SCREWS Smith & Nephew Richards, Inc. KWP Class II 1997-05-08
K971297 CENTRE-DRIVE DRILL-FREE SCREW KLS-Martin L.P. HRS Class II 1997-05-08
K965102 ACROMED PEDICLE SCREW Acromed Corp. MNH Class II 1997-05-08
K963562 WRIGHT PLASTER OF PARIS PELLETS Wrightmedicaltechnologyinc MQV Class II 1997-05-07
K963396 BIOSPHERE SUTURE ANCHOR Instrument Makar, Inc. MAI Class II 1997-05-06
K964178 PRESS-FIT HIP STEM Encore Orthopedics, Inc. LWJ Class II 1997-05-05
K970490 PROFORM GENERAL APPLICATION CEMENTED FEMORAL COMPONENT Stelkast Company LZO Class II 1997-05-02
K964797 EBI SPINELINK SYSTEM Electro-Biology, Inc. KWQ Class II 1997-05-02
K970870 DIGIT-GRIP WITH LCD (DGR002) Nk Biotechnical Corp. HRW Class I 1997-05-02
K970806 ACPII ANTERIOR CERVICAL PLATE SYSTEM Sofamor Danek USA,Inc. KWQ Class II 1997-05-02
K970503 DEPUY ACE TROCHANTERIC SIDE PLATE Depuy Ace Medical Co. HRS Class II 1997-04-30
K970447 IMPLEX BIPOLAR HIP SYSTEM Implex Corp. KWY Class II 1997-04-30
K970498 NATURAL-KNEE II REVISION FEMORAL SPACER LUGS Intermedics Orthopedics JWH Class II 1997-04-30
K970501 PEGGED ACETABULAR COMPONENT Biomet, Inc. LPH Class II 1997-04-30
K970423 INNOVASIVE ROCLET BONE TUNNEL AUGMENTATION DEVICE Innovasive Devices, Inc. MBI Class II 1997-04-30
K970549 TITANIUM ALLOY BONE SCREWS Aesculap, Inc. HWC Class II 1997-04-30
K964400 ALPHATEC EXTERNAL FIXATION SYSTEM Alphatec Mfg., Inc. KTT Class II 1997-04-28
K970697 OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM Osteonics Corp. JDI Class II 1997-04-24
K970292 IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW Influence, Inc. MBI Class II 1997-04-23
K970394 OSTEONICS NORMALIZED AD-HA ACETABULAR COMPONENT SYSTEM Osteonics Corp. MEH Class II 1997-04-22
K970897 BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM Biodynamic Technologies, Inc. HSB Class II 1997-04-21
K964254 TITANIUM LIBERTY POSTERIOR SPINAL SYSTEM Sofamor Danek USA,Inc. KWP Class II 1997-04-21
K970284 ARTOS, DIPLOS SYSTEM Turnkey Intergration USA, Inc. KWY Class II 1997-04-21
K970751 HEIDELBERG EXTERNAL FIXATOR Smith & Nephew, Inc., Orthopaedic Div. JDW Class II 1997-04-16
K970316 INNOVASIVE 8MM LIGAMENT FASTENER Innovasive Devices, Inc. MBI Class II 1997-04-16
K970194 PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENT Stelkast Company JDI Class II 1997-04-14
K964533 EBI SPINELINK SYSTEM Electro-Biology, Inc. MNH Class II 1997-04-09
K970200 RELIANCE PF FEMORAL STEMS Howmedica Corp. LZO Class II 1997-04-09
K970166 NATURAL-HIP SYSTEM COCR REVISION STEM Intermedics Orthopedics LZO Class II 1997-04-08
K970713 COMPASS UNIVERSAL HINGE Smith & Nephew, Inc., Orthopaedic Div. JDW Class II 1997-04-03
K961388 ATLAS III ACETABULAR CUP Fournitures Hospitalieres MEH Class II 1997-04-03
K970462 ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM Acromed Corp. KWQ Class II 1997-04-03
K964970 BIOMET BONE SCREW Biomet, Inc. HWC Class II 1997-04-03
K961260 KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY Biomet, Inc. HSD Class II 1997-04-02
K970031 FOUNDATION KNEE SYSTEM TIBIAL COMPONENT Encore Orthopedics, Inc. JWH Class II 1997-04-02
K970733 SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM Synthes (Usa) HTY Class II 1997-04-02
K970290 EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM Ebi, L.P. KTT Class II 1997-04-01
K964404 BACFIX SPINAL FIXATION SYSTEM Spinal Concepts, Inc. KWP Class II 1997-03-26
K964024 DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEM Depuy, Inc. KWP Class II 1997-03-26
K970036 FIXATION PIN OR ROD United States Surgical, A Division of Tyco Healthc HTY Class II 1997-03-25
K963325 SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM Synthes (Usa) HRS Class II 1997-03-25
K970089 INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER Innovasive Devices, Inc. MBI Class II 1997-03-25

17,115 clearances in the Orthopedic panel. Data: openFDA.