meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
26
Latest Decision
1995-11-14

Clearances · page 142 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K954509 PROBE KNIFE Phx Technologies Corp. HRX Class II 1995-11-14
K954508 RETRACTOR Phx Technologies Corp. HRX Class II 1995-11-14
K954510 RRIANGLE KNIFE Phx Technologies Corp. HRX Class II 1995-11-14
K954465 FMS DUO Future Medical Systems, Inc. HRX Class II 1995-11-09
K953730 CODMAN ANTERIOR CERVICAL PLATE SYSTEM Johnson & Johnson Professionals, Inc. KWQ Class II 1995-11-09
K942029 ARTHROSCOPE Surgical Technologies, Inc. HRX Class II 1995-11-08
K950275 RESORBABLE SOFT TISSUE ATTACHMENT DEVICE Zimmer, Inc. MAI Class II 1995-11-07
K953779 SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM Advanced Spine Fixation Systems, Inc. MNH Class II 1995-11-07
K953792 CONSENSUS ZIRCONIA HEAD SIZE -3.5, 0, +5 U.S. Medical Products, Inc. LZO Class II 1995-11-06
K950011 COHORT(TM) ANTERIOR PLATE SYSTEM (APS) Cohort Medical Products Group, Inc. KWQ Class II 1995-11-06
K953778 SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEM Advanced Spine Fixation Systems, Inc. MNH Class II 1995-11-06
K954014 PERCUTANEOUS DISCECTOMY CANNULA SYSTEM T. Korossurgical Instruments Corp. HRX Class II 1995-11-06
K954052 ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTES T. Korossurgical Instruments Corp. HRX Class II 1995-11-06
K953653 LUBINUS SP II HIP SYSTEM Turnkey Intergration USA, Inc. JDG Class II 1995-11-06
K953650 DEPUY STAINLESS STEEL SET SCREW Depuy, Inc. HWC Class II 1995-11-03
K954262 NEXUS II FEMORAL COMPONENT Wrightmedicaltechnologyinc JDI Class II 1995-11-03
K954440 APEX TUBING SET Linvatec Corp. HRX Class II 1995-11-02
K953720 AESCULAP CASPAR PLATE & SCREW SYSTEM FOR ANTERIOR CERVICAL FUSION Aesculap, Inc. KWQ Class II 1995-11-02
K954712 INTRAMEDULLARY HIP SCREW (MODIFICATION) Smith & Nephew Richards, Inc. KTT Class II 1995-10-31
K953334 SYNTHES FLEXNAIL Synthes (Usa) HSB Class II 1995-10-31
K951451 PEBA ANCHOR (MULTIPLE SIZES) Orthopaedic Biosystems, Ltd. MBI Class II 1995-10-31
K953397 HEX-FIX FIELD FIXATOR Smith & Nephew Richards, Inc. LXT Class II 1995-10-31
K954485 6.5MM SOLID CANCELLOUS BONE SCREW Ace Medical Co. HWC Class II 1995-10-31
K953194 LACTOSORB BONE PIN Biomet, Inc. HTY Class II 1995-10-31
K953406 EBI X FIX DYNAFIX SYSTEM (DFS) Electro-Biology, Inc. KTT Class II 1995-10-31
K954647 INCLINOMETER J-Tech, Inc. KQX Class I 1995-10-30
K953578 PROTEK ACETABULAR ROOF REINFORCEMENT RING Intermedics Orthopedics JDI Class II 1995-10-30
K953635 TITANIUM DYNA-LOK SPINAL SYSTEM Sofamor Danek USA,Inc. MNH Class II 1995-10-30
K954001 SPETZLER PIN Howmedica Corp. HTY Class II 1995-10-26
K954213 ATH FULL PROFILE ACETABULAR CUP SYSTEM Kinamed, Inc. LPH Class II 1995-10-25
K953702 WASHER Linvatec Corp. MBI Class II 1995-10-25
K950709 SYNERGY TI ANTERIOR SPINAL SYSTEM Cross Medical Products, Inc. KWQ Class II 1995-10-25
K954463 DISSECTING OBTURATOR Phx Technologies Corp. HRX Class II 1995-10-23
K954193 SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET Surgical Dynamics, Inc. HRX Class II 1995-10-23
K954217 ARTHROPLAST & ARTHRO-CUTTER Future Medical Systems, Inc. HRX Class II 1995-10-23
K954475 BLUNT DISSECTOR, CURVED Phx Technologies Corp. HRX Class II 1995-10-23
K954459 CONICAL OBTURATOR Phx Technologies Corp. HRX Class II 1995-10-23
K954458 BOAT NOSE OBTURATOR Phx Technologies Corp. HRX Class II 1995-10-23
K954476 PROBE Phx Technologies Corp. HRX Class II 1995-10-23
K953664 VITALOCK SPIKED ACETABULAR SHELL Howmedica Corp. LPH Class II 1995-10-23
K954464 CARPAL TUNNEL SLOTTED CANNULA Phx Technologies Corp. HRX Class II 1995-10-23
K953264 QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM Wrightmedicaltechnologyinc MBI Class II 1995-10-20
K953490 TRILOGY ACETABULAR SHELL & LINERS 36MM Zimmer, Inc. LPH Class II 1995-10-20
K944689 ZIRCONIA CERAMIC FEMORAL HEAD Wrightmedicaltechnologyinc LZO Class II 1995-10-20
K953818 DALL-MILES SUTURE/BEADED CABLE Howmedica Corp. JDQ Class II 1995-10-12
K950209 J.B.S. ANTERIOR SPINE SYSTEM(R) J.B.S. (Usa), Inc. KWQ Class II 1995-10-11
K953276 ACUFEX TAG DELIVERY SYSTEM Acufex Microsurgical, Inc. JDR Class II 1995-10-05
K952330 EXTERNAL FIXATOR Acu Med, Inc. JEC Class II 1995-10-05
K953416 BRYAN POSTERIOR SPINAL FIXATOR (BPSF) Arcan Orthopaedic Corp. MNH Class II 1995-10-03
K953659 ARTHROSCOPIC ELECTROSURGERY SYSTEM (MODIFICATION) Arthrocare Corp. HRX Class II 1995-09-29
K952923 INTRAMEDULLARY COMPRESSION ARTHRODESIS (ICA) NAIL Howmedica Corp. HSB Class II 1995-09-29
K953868 GRASPING FORCEPS, BIOPSY FORCEPS, SCISSORS, PUNCH Richard Wolf Medical Instruments Corp. HRX Class II 1995-09-29
K952460 STRYKER ACL INTERFERENCE SCREW SYSTEM Stryker Endoscopy HWC Class II 1995-09-28
K953045 BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD Biologically Oriented Prostheses LZO Class II 1995-09-27
K952928 AEQUALIS SHOULDER SYSTEM FOR TOTAL & HEMISHOULDER APPLICATIONS Tornier KWS Class II 1995-09-27
K930191 DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY Sofamor Danek Mfg., Inc. HRX Class II 1995-09-26
K953531 HOWMEDICA MAINSTAY ANCHOR Howmedica Corp. JDR Class II 1995-09-26
K944538 GAS PLASMA STERILIZATION Depuy, Inc. HRY Class II 1995-09-26
K952686 BUCHALTER FAUSER FEMORAL COMPONENTS Biomet, Inc. LZO Class II 1995-09-19
K952068 ETHYLENE OXIDE STERILIZATION OF POLYETHYLENE ORTHOPEDIC DEVICES Zimmer, Inc. HSX Class II 1995-09-19
K940861 PCA(R) MODULAR TOTAL KNEE TIB INSERT DUROCON BASEPLATE Howmedica Corp. JWH Class II 1995-09-18
K940743 UHMWPE COMPONENTS-CHANGE IN PACKAGING Depuy, Inc. KWY Class II 1995-09-18
K952739 ORTHONAIL Orthologic Corp. HSB Class II 1995-09-15
K952783 OXBORO-MEDICAL PIN COVERS Oxboro Medical Intl., Inc. LRN Class II 1995-09-15
K952831 BIOSCREW ABSORBABLE INTERFERENCE SCREW Linvatec Corp. HWC Class II 1995-09-15
K953695 DYONICS DISPOSABLE ARTHROSCOPIC BLADES Smith & Nephew Dyonics, Inc. HRX Class II 1995-09-15
K934327 ARTHREX SUTURE ANCHOR SCREW SYSTEM Arthrex, Inc. MBI Class II 1995-09-15
K946174 BLOCK(TM) ARTHROSCOPIC TOOL KIT Johnson HRX Class II 1995-09-14
K953033 PRIME CEMENTED SMALL FEMORAL STEM Orthopaedic Innovations, Inc. JDI Class II 1995-09-13
K952697 TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM Smith & Nephew Richards, Inc. HWC Class II 1995-09-12
K952630 DISPOSABLE BIOPSY FORCEP Neuro Navigational Corp. HRX Class II 1995-09-08
K952629 NEXFLEX TOTAL HIP SYSTEM Nexmed, Inc. JDI Class II 1995-09-08
K952271 GENESIS CONSTRAINED SYSTEM (GCS) Smith & Nephew Richards, Inc. JWH Class II 1995-09-08
K953369 STAINLESS STEEL VARIFIX SYSTEM 5.0MM DIAMETER ANCHOR SCREW Advanced Spine Fixation Systems, Inc. MNH Class II 1995-09-08
K951565 INNOVASIVE DEVICES ROTATOR CUFF FASTENER Innovasive Devices, Inc. MBI Class II 1995-09-08
K951725 OSTEONICS SPINAL SYSTEM Osteonics Corp. MNH Class II 1995-09-08
K944553 PRESSURE SENSING SCOPE SHEATH SYSTEM Linvatec Corp. HRX Class II 1995-09-08
K952730 HOFFMANN II EXTERNAL FIXATION SYSTEM Howmedica Corp. JEC Class II 1995-09-08
K952639 DISPOSABLE TOOTHED GRASPING FORCEP Neuro Navigational Corp. HRX Class II 1995-09-08
K953025 SLT 28MM XXL FEMORAL HEAD Wrightmedicaltechnologyinc JDI Class II 1995-09-08
K951671 OSTEONICS RESTORATION MONOLITHIC II SLOTTED HIP STEM SERIES Osteonics Corp. MEH Class II 1995-09-06
K930084 MICRO-ARTHROSCOPE Medical Devices, Inc. HRX Class II 1995-09-01
K951932 OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES Osteonics Corp. MEH Class II 1995-09-01
K944593 STRYKER PRESSURE SENSING CANNULA Stryker Endoscopy HRX Class II 1995-09-01
K950865 ROGOZINSKI SPINAL ROD SYSTEM ROD-TO-BOLT (UNIVERSAL) CONNECTOR FOR USE WITH THE SIMMONS PLATING SYSTEM BOLT Smith & Nephew Richards, Inc. MNH Class II 1995-09-01
K953484 POLLUX OA/POLLUX 30A/POLLUX 70A Pollux Endoscopy, Inc. HRX Class II 1995-09-01
K953075 UNIMAT PUMP KARL STORZ Endoscopy-America, Inc. HRX Class II 1995-09-01
K951267 STRYKER UNIVERSAL ACL INSTRUMENTATION SYSTEM Stryker Endoscopy HRX Class II 1995-09-01
K940537 KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM Kirschner Medical Corp. KWT Class II 1995-08-29
K950596 GDLH POSTERIOR SPINAL SYSTEM Sofamor Danek USA,Inc. MNH Class II 1995-08-28
K942889 SB ANCHOR Orthopaedic Biosystems, Ltd. JDR Class II 1995-08-25
K951232 EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM American Medical Electronics, Inc. HWC Class II 1995-08-25
K950955 PARAGON POSTERIOR SPINAL SYSTEM Sofamor Danek USA,Inc. MNH Class II 1995-08-25
K953764 LMT BONE ANCHOR Li Medical Technologies, Inc. JDR Class II 1995-08-25
K943725 UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM Synthes Spine KWQ Class II 1995-08-25
K953550 CO2 ARTHROFLATOR KARL STORZ Endoscopy-America, Inc. HRX Class II 1995-08-23
K953459 ACUFEX TAG ANCHOR Acufex Microsurgical, Inc. MBI Class II 1995-08-23
K951987 GENESIS II TOTAL KNEE SYSTEM Smith & Nephew Richards, Inc. JWH Class II 1995-08-22
K953067 HIP FRACTURE STEM FENESTRATION PLUG Howmedica Corp. JDG Class II 1995-08-21
K951794 SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM) Synthes (Usa) MNH Class II 1995-08-21

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