meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
31
Latest Decision
1996-02-09

Clearances · page 141 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K955171 NEXLOCK FEMORAL STEM Nexmed, Inc. JDG Class II 1996-02-09
K954682 WASHER, BOLT, NUT, ORTHOPEDIC Linvatec Corp. HTN Class II 1996-02-09
K955480 BOZOTTA REINSERTION FORCEPS KARL STORZ Endoscopy-America, Inc. HRX Class II 1996-02-09
K951164 CD LIBERTY POSTERIOR SPINCAL SYSTEM Sofamor Danek USA,Inc. KWP Class II 1996-02-09
K955914 LIMITED REUSE ARTHROSCOPIC BLADES Smith & Nephew Dyonics, Inc. HRX Class II 1996-02-08
K952687 PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM ETHICON, Inc. MAI Class II 1996-02-06
K955099 SORBIE TOTAL ELBOW SYSTEM Wrightmedicaltechnologyinc JDB Class II 1996-02-05
K955500 FMS ARTHOPROBE Future Medical Systems, Inc. HRX Class II 1996-02-05
K953274 GENESIS POROUS TIBIAL TRAYS & REVISION KNEE SYSTEM Smith & Nephew Richards, Inc. JWH Class II 1996-02-05
K953694 DEPUY VISION AML HIP PROTHESIS Depuy, Inc. LPH Class II 1996-02-01
K953703 DEPUY VISION SOLUTION HIP PROSTHESIS Depuy, Inc. LPH Class II 1996-02-01
K955003 BIOFIX BIODEGRADABLE SELF-REINFORCED POLY-L-LACTIDE (SR-PLLA) MINI-TACK Bioscience, Inc. MAI Class II 1996-01-31
K954909 PROFIX POSTERIOR-STABILIZED KNEE SYSTEM Smith & Nephew Richards, Inc. JWH Class II 1996-01-31
K953200 ULTIMA SIZE 0 CEMENTED FEMORAL STEM Johnson & Johnson Professionals, Inc. JDI Class II 1996-01-31
K955033 RIM FLARE ACETABULAR COMPONENT Intermedics Orthopedics LPH Class II 1996-01-31
K953560 MITEK THREADED ANCHOR (FASTIN) Mitek Surgical Products, Inc. MBI Class II 1996-01-31
K955388 ACE-DUPONT COMPOSITE RINGS Ace Medical Co. LXT Class II 1996-01-31
K953202 P.F.C. SIZE 0 CEMENTED FEMORAL COMPONENT Johnson & Johnson Professionals, Inc. JDI Class II 1996-01-31
K953925 FINE GRAIN CAST COBALT CHROMIUM HIP STEMS Biomet, Inc. LZO Class II 1996-01-31
K954443 LACTOSORB SUTURE ANCHOR Poly-Medics,Inc. JDR Class II 1996-01-31
K952859 ULTIMA CEMENTED LONG STEM FEMORAL COMPONENT Johnson & Johnson Professionals, Inc. JDI Class II 1996-01-31
K953350 MLI INTERFERENCE SCREW Medicinelodge, Inc. HWC Class II 1996-01-30
K940744 SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION Sofamor Co. KWQ Class II 1996-01-30
K955385 JOHNSON & JOHNSON AUSTIN MOORE STEM Johnson & Johnson Professionals, Inc. KWL Class II 1996-01-30
K955271 MICRO-SEAL ACETABULAR SYSTEM Whiteside Instruments LPH Class II 1996-01-30
K953439 ULTRACK TOTAL KNEE SYSTEM Wrightmedicaltechnologyinc JWH Class II 1996-01-30
K954186 SLED UNICOMPARTMENT KNEE SYSTEM Link America, Inc. HSX Class II 1996-01-26
K944544 ABSORBABLE BONE SCREW Johnson & Johnson Professionals, Inc. MAI Class II 1996-01-26
K954684 DEPUY ANATOMIC MODULAR KNEE (AMK) CONGRUENCY POSTERIOR STABILIZED TIBIAL INSERT Depuy, Inc. JWH Class II 1996-01-26
K954555 VERSA-FX FEMORAL FIXATION SYSTEM Zimmer, Inc. KTT Class II 1996-01-26
K953977 PRIMALOC CEMENTLESS HIP SYSTEM Ortho Development Corp. KWY Class II 1996-01-26
K955320 PROTEC COTTON PADDING BANDAGE Derivadas Degasa S.A. DE C.V. LGF Class I 1996-01-26
K954770 CENTRA-LINE GRAPPLE, VARIFIX SYSTEM Advanced Spine Fixation Systems, Inc. KWP Class II 1996-01-25
K954016 VIDEOSCOPE W/IRRIGATION SHEATH T. Korossurgical Instruments Corp. HRX Class II 1996-01-25
K945303 ARTHREX BIOABSORBABLE INTERFERENCE SCREW Arthrex, Inc. HWC Class II 1996-01-25
K954756 FIXANO I.F.O (INTERLOCKING FLEXIBLE OSTEOSYNTHESIS) SYSTEM Ferguson Medical HSB Class II 1996-01-25
K954757 FIXANO D.D.S. (DOUBLE SLIDING SCREW) Ferguson Medical HWC Class II 1996-01-25
K950999 KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS Buckman Co., Inc. MNH Class II 1996-01-25
K954838 EZ FIX Biodynamic Technologies, Inc. JEC Class II 1996-01-24
K955354 ALTERNATIVE STERILIZATION PROCESS Howmedica Corp. JDI Class II 1996-01-24
K954744 ZCH ALPHA SYSTEM Zimmer, Inc. JDI Class II 1996-01-23
K952495 ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM Orthopedic Systems, Inc. LXH Class I 1996-01-22
K954935 S-ROM FEMORAL HIP STEM - SIZE 14 X 8 Joint Medical Products Corp. LPH Class II 1996-01-22
K953913 OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIES Optus, Inc. HRX Class II 1996-01-22
K953337 BETA HIP PROSTHESIS Zimmer, Inc. LPH Class II 1996-01-22
K952236 ISOLA SYSTEM Acromed Corp. MNH Class II 1996-01-22
K950272 PANALOK ABSORBABLE SUTURE ANCHOR SYSTEM ETHICON, Inc. JDR Class II 1996-01-18
K952830 DARWIN KNEE SYSTEM (TC3) Johnson & Johnson Professionals, Inc. JWH Class II 1996-01-18
K955305 PCA +15MM MODULAR FEMORAL HEAD Howmedica Corp. MEH Class II 1996-01-18
K954768 BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD Biologically Oriented Prostheses LZO Class II 1996-01-18
K954698 TRILOGY ACETABULAR COMPONENT 7MM OFFSET Zimmer, Inc. LPH Class II 1996-01-17
K954811 DEPUY ADVANTAGE HIP FEMORAL PROSTHESIS WITH POROCOAT Depuy, Inc. LPH Class II 1996-01-17
K953268 DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT Stelkast Company LWJ Class II 1996-01-17
K952970 HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESM Howmedica Corp. JDI Class II 1996-01-17
K955652 KARL STORZ TARGETING UNIT KARL STORZ Endoscopy-America, Inc. HRX Class II 1996-01-17
K954148 SUTURE WASHER Acu Med, Inc. HTN Class II 1996-01-17
K951517 OSTEONICS SECUR-FIT HA PLUS HIP STEM SERIES Osteonics Corp. MEH Class II 1996-01-17
K954645 TITANIUM GDLH POSTERIOR SPINAL SYSTEM Sofamor Danek USA,Inc. KWP Class II 1996-01-16
K954667 MONOTUBE TUBE-TO-TUBE CLAMP Howmedica Corp. JEC Class II 1996-01-11
K953877 MITEK GII ANCHOR Mitek Surgical Products, Inc. MBI Class II 1995-12-29
K952731 TOWNLEY ALL POLY ACETABULAR CUP Biologically Oriented Prostheses JDI Class II 1995-12-28
K945774 BETA FEMORAL HIP STEM Wrightmedicaltechnologyinc JDI Class II 1995-12-28
K954964 AQUACENTER 2000 SYSTEM Aquarius Medical Corp. HRX Class II 1995-12-28
K954915 FLEXIBLE INTRAMEDULLARY REAMER Zimmer, Inc. HTO Class I 1995-12-28
K954511 GO INTRAMEDULLARY NAIL LOCKING SCREW Genesis Orthopedics, Inc. HWC Class II 1995-12-19
K936294 SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS Sofamor Danek Mfg., Inc. KWP Class II 1995-12-19
K953599 CLAMP ASSEMBLY J.B.S., S.A. KWP Class II 1995-12-19
K954627 ECTRA II LIGAMENT RELEASE SYSTEM Smith & Nephew Dyonics, Inc. HRX Class II 1995-12-18
K955471 INCL ENDOSCOPE Sofamor Danek USA,Inc. HRX Class II 1995-12-18
K952298 SPINAL PEDICLE SCREW, FIXATION, APPLIANCE J.B.S., S.A. MNH Class II 1995-12-13
K954554 ALTA TIBIAL/HUMERAL ROD Howmedica Corp. HSB Class II 1995-12-13
K935585 APR ACETABULAR INSERTS IOI BIPOLAR Intermedics Orthopedics JDI Class II 1995-12-13
K952766 RAYHACK OSTEOTOMY SYSTEM (MODIFICATION) Creative Medical Designs, Inc. HRS Class II 1995-12-13
K954630 DEPUY TITANIUM CROSS PIN FIXATION SYSTEM Depuy, Inc. JDW Class II 1995-12-13
K954417 A-B ACETABULAR COMPONENT Biomet, Inc. LPH Class II 1995-12-11
K952237 INNOVASICE 2.8MM & 3.5MM ROC SUTURE BONE FASTENER Innovasive Devices, Inc. MBI Class II 1995-12-08
K955273 CANNULOC THREADED CANNULA Linvatec Corp. HRX Class II 1995-12-08
K954330 SUPER SCREW 3.5 MM Osteomed Corp. HWC Class II 1995-12-08
K954543 GO UNIVERSALK-WIRE FLUTED DRILL Genesis Orthopedics, Inc. HTY Class II 1995-12-08
K954981 KARL STORZ HEMPFLING DILATION SET KARL STORZ Endoscopy-America, Inc. HRX Class II 1995-12-04
K954219 REALITY LONG STEM HIP SYSTEM Kinamed, Inc. JDI Class II 1995-12-04
K955272 TAKE-APART ARTHRO-SCISSORS, GASPING, BIOPSY PUNCH FORCEPS FOR ARTHROSCOPY KARL STORZ Endoscopy-America, Inc. HRX Class II 1995-12-04
K955037 RIGID NEUROVIEW ENDOSCOPE Neuro Navigational Corp. HRX Class II 1995-12-04
K953998 DISCETOME TISSUE ASPIRATOR T. Korossurgical Instruments Corp. HRX Class II 1995-12-04
K954466 PROFORM POROUS BEADED FEMORAL STEM Stelkast Company LPH Class II 1995-12-04
K954534 OSTEONICS UNIPOLAR ENDO HEAD Osteonics Corp. KWL Class II 1995-11-30
K954288 EXTEND HIP SYSTEM Wrightmedicaltechnologyinc LPH Class II 1995-11-30
K953689 WAGNER REVISION STEM (MODIFICATION) Intermedics Orthopedics LZO Class II 1995-11-29
K953688 CLS ACETABULAR COMPONENT (MODIFICATION) Intermedics Orthopedics LZO Class II 1995-11-29
K954289 SYNTHES CANNULATED ANGLE BLADE PLATE Synthes (Usa) KTW Class II 1995-11-24
K953198 CORTICELLOUS BONE SCREW Hayes Medical, Inc. HWC Class II 1995-11-24
K951139 ALPHA LONG STEM FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL) Wrightmedicaltechnologyinc JDI Class II 1995-11-22
K954023 OSTEONICS SECUR-FIT HA PSL EXTRA ACETABULAR COMPONENT SYSTEM Osteonics Corp. MEH Class II 1995-11-22
K946087 INCLUSICE II(TM) ENDOSCOPE Sofamor Danek USA,Inc. HRX Class II 1995-11-21
K951266 AMSET R-F SYSTEM Advanced Spine Technology, Inc. MNH Class II 1995-11-21
K954138 DURACON MONOLITHIC STABILIZER FEMORAL COMPONENT Howmedica Corp. JWH Class II 1995-11-21
K953714 ZIMMER RECONSTRUCTION SYSTEM SYMPHYSEAL BONE PLATE Zimmer, Inc. HRS Class II 1995-11-20
K954882 RIZA-RIBE NEEDLE (MODIFICATION) R-Med, Inc. HRX Class II 1995-11-16
K954077 UNITRAX V40 MODULAR ADAPTOR Howmedica Corp. KWL Class II 1995-11-15
K954507 RETROGRADE KNIFE Phx Technologies Corp. HRX Class II 1995-11-14

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