meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
28
Latest Decision
1994-12-05

Clearances · page 146 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K942341 CANNULATED CANCELLOUS BONE SCREW Acu Med, Inc. HWC Class II 1994-12-05
K942340 CORTICAL BONE SCREW Acu Med, Inc. HWC Class II 1994-12-05
K941367 WEBB-MORLEY SPINE SYSTEM Electro-Biology, Inc. KWQ Class II 1994-12-05
K930771 PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM Orthomet, Inc. JDI Class II 1994-11-30
K935921 ZIRCONIA CERAMIC FEMORAL HEAD Smith & Nephew Richards, Inc. LZO Class II 1994-11-28
K944883 GAMMA LOCKING NAIL - LONG LENGTH Howmedica Corp. KTT Class II 1994-11-28
K941866 PIONEER LABORATORIES CABLE SCREW Pioneer Surgical Technology HWC Class II 1994-11-28
K943323 STRYKER SURGICAL INSTRUMENTS AND ACCESSORIES Stryker Corp. HRX Class II 1994-11-28
K944501 TRUE/FLEX INTRAMEDULLARY ROD END-CAP Applied Osteo Systems, Inc. HSB Class II 1994-11-28
K943898 SAUNDERS ELECTRONIC INCLINOMETER The Saunders Group KQX Class I 1994-11-28
K940287 MENISCAL SUTURE INSTRUMENTARIUM Richard Wolf Medical Instruments Corp. HRX Class II 1994-11-22
K943628 ARTHROSCOPE Electro Fiberoptics Corp. HRX Class II 1994-11-22
K940690 PIONEER LABORATORIES BONE SCREW Pioneer Surgical Technology HWC Class II 1994-11-22
K943676 DANEKSCOPE OPTI-PROBE Danek Medical, Inc. HRX Class II 1994-11-21
K940812 INSIGHT ELECTRONIC ALIGNMENT INDICATOR Andronic Devices, Ltd. KQX Class I 1994-11-21
K942427 ENVISION ARTHROSCOPE, CANNULA,TROCAR, OBTURATOR, AND PROBE Envision Surgical System, Inc. HRX Class II 1994-11-17
K943666 ENVISION ARTHROSCOPY VISUALIZATION SYSTEM Envision Surgical System, Inc. HRX Class II 1994-11-17
K936256 MODULAR CERAMIC FEMORAL HEAD Stelkast Company LZO Class II 1994-11-14
K940669 J.B.S. B.A.C. PIN J.B.S., S.A. HTY Class II 1994-11-14
K940673 J.B.S. SELF-TAPPING THREADED PIN J.B.S., S.A. HTY Class II 1994-11-14
K940666 JBS SMOOTH FIXATION PIN J.B.S., S.A. HTY Class II 1994-11-14
K940713 PCA MODULAR PRIMARY/REVISION PATELLA Howmedica Corp. JWH Class II 1994-11-10
K941333 SE5 ARTHROSCOPY SYTEM Stryker Endoscopy HRX Class II 1994-11-10
K942370 DEPUY CEMENTED HIP PROSTHESIS Depuy, Inc. JDI Class II 1994-11-10
K942603 ORTHOPAEDIC WIRES Acu Med, Inc. LRN Class II 1994-11-09
K942081 ENVISION ARTHROSCOPY SYSTEM Envision Surgical System, Inc. HRX Class II 1994-11-09
K934756 CODMAN ANTERIOR CERVICAL SPINE PLATE SYSTEM Codman & Shurtleff, Inc. KWQ Class II 1994-11-08
K933539 FOUNDATION POSTERIOR STABILIZED KNEE Encore Orthopedics, Inc. JWH Class II 1994-11-08
K943985 LIMITED REUSE BLADES Linvatec Corp. HRX Class II 1994-11-07
K941896 STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR Depuy, Inc. LXH Class I 1994-11-07
K942891 SUMMIT TOTAL HIP SYSTEM Kirschner Medical Corp. MEH Class II 1994-11-02
K943300 DEPUY POROUS COATED GLOBAL SHOULDER Depuy, Inc. KWS Class II 1994-10-31
K936127 HOWMEDICA PREMIUM FEMORAL COMPONENT Howmedica, Inc. JDI Class II 1994-10-26
K935726 EXACTECH POROUS COATED CRUCIATE RETAINED FEMORAL COMPONENT Exactech, Inc. JWH Class II 1994-10-20
K932776 CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTS Exactech, Inc. JWH Class II 1994-10-20
K943472 COHORT AVB RETRACTOR SYSTEM Cohort Medical Products Group, Inc. HXB Class I 1994-10-20
K936126 HOWMEDICS DRG FEMORAL COMPONENT Howmedica, Inc. JDI Class II 1994-10-20
K934429 ANTERIOR SPINE SYSTEM Buckman Co., Inc. KWQ Class II 1994-10-20
K943539 AIMS CANNULATED ACL SCREW Smith & Nephew, Inc. HWC Class II 1994-10-19
K935113 J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE J.B.S., S.A. KWP Class II 1994-10-19
K935321 INNOVASIVE SUTURE BONE FASTENER WITH SUTURE Innovasive Devices, Inc. JDR Class II 1994-10-19
K926334 AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER Orthomet, Inc. JWH Class II 1994-10-18
K943586 ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET) Biomet, Inc. LZO Class II 1994-10-17
K935593 ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM Biodynamic Technologies, Inc. HSD Class II 1994-10-14
K943474 CANNULATED BONE SCREW Cohort Medical Products Group, Inc. HWC Class II 1994-10-14
K933942 SOLUTION BOWED FEMORAL HIP PROTSTHESIS Depuy, Inc. LZO Class II 1994-10-14
K931333 ORTHOMET ACETABULAR CUP SYSTEM Orthomet, Inc. LPH Class II 1994-10-14
K941606 PRESERVATION UNICOMPARTMENTAL KNEE Depuy, Inc. HSX Class II 1994-10-14
K932677 AXIOM TOTAL KNEE SYSTEM Orthomet, Inc. JWH Class II 1994-10-14
K943302 AML TRI-LOCK REPLACEMENT LINER SYSTEM Depuy, Inc. JDI Class II 1994-10-14
K942966 AML TRILOCK REPLACEMENT LINER SYSTEM Depuy, Inc. JDI Class II 1994-10-14
K925613 PROXIMAL HUMERAL REPLACEMENT SYSTEM Biomet, Inc. KWT Class II 1994-10-14
K931423 PARADIGM FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM Orthomed LWJ Class II 1994-10-13
K940847 ENDOSCOPIC PLANTAR FASCIA KIT Citation Medical Corp. HRX Class II 1994-10-11
K933935 CKS POROUS COATED FEMORAL COMPONENT Techmedica, Inc. HRY Class II 1994-10-11
K935295 ALTA FEMORAL INTRAMEDULLARY RODS/CFX RODS MODIFICATION Howmedica Corp. HSB Class II 1994-10-11
K941718 3M FLUID CONTROL SYSTEM 8300 CASSETTE LOAD 3M Medical Products Group HRX Class II 1994-10-07
K934366 MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER Mitek Surgical Products, Inc. HWC Class II 1994-10-07
K934707 GALILEO ARTHROSCOPES Galileo Electro-Optics Corp. HRX Class II 1994-10-07
K941388 3M FLUID IRRIGATION SYSTEM 3M Healthcare HRX Class II 1994-10-07
K931752 CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATION Corin Orthopedic Products KWL Class II 1994-10-07
K931753 CORIN THOMPSON PROSTHESIS, MODIFICATION Corin Orthopedic Products KWL Class II 1994-10-07
K931960 NUFFIELD TOTAL KNEE Turnkey Intergration USA, Inc. JWH Class II 1994-10-07
K941617 APR ACETABULAR INSERT Intermedics Orthopedics JDI Class II 1994-10-06
K935452 P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT Johnson & Johnson Orthopaedics, Inc. LZO Class II 1994-10-06
K940235 ORTHOLOC ADVANTIM PS LSI TIBIAL INSERT Wrightmedicaltechnologyinc JWH Class II 1994-10-05
K942406 OPTION SHELL Intermedics Orthopedics JDI Class II 1994-10-05
K943054 OSTEONICS SECURE-FIT AD ACETABULAR COMPONENT SYSTEM Osteonics Corp. LPH Class II 1994-10-04
K942330 APR II FEMORAL COMPONENT (VARIOUS) Intermedics Orthopedics LZO Class II 1994-10-04
K940913 SPINE-TECH LAPAROSCOPIC INSTRUMENTATION SYSTEM Spine-Tech, Inc. HRX Class II 1994-10-04
K936037 S-ROM NOILES CRUCIATE RETAINING KNEE Joint Medical Products Corp. JWH Class II 1994-10-03
K941434 K-WIRES AND STEINMANN PINS Omega Surgical Instruments, Inc. HTY Class II 1994-10-03
K941048 TRUE/LOK MONOLATERAL/BILATERAL FIXATOR Applied Osteo Systems, Inc. LXT Class II 1994-10-03
K942101 4-LEAD IRRIGATION SET Douglas Medical Products Corp. HRX Class II 1994-09-30
K943160 INTERFERENCE SCREW Applied Osteo Systems, Inc. HWC Class II 1994-09-30
K940190 ULTIMA UNIPOLAR MODULAR HEAD Johnson & Johnson Orthopaedics, Inc. KWL Class II 1994-09-29
K942115 INFINITY REVISION HIP STEM Wrightmedicaltechnologyinc LPH Class II 1994-09-28
K941036 CURVED ROTATABLE DISPOSABLE ARTHROSCOPIC SURGERY BLADES Smith & Nephew, Inc. HRX Class II 1994-09-28
K941964 LMT ARTHROSCOPIC SUTURING INSTRUMENTS Li Medical Technologies, Inc. HRX Class II 1994-09-28
K926417 ALPHATEC 130-150 SLOTTED COMPRESSION HIP SCREW Alphatec Mfg., Inc. KTT Class II 1994-09-28
K942079 MANUAL SURGICAL INSTRUMENTS Acufex Microsurgical, Inc. HRX Class II 1994-09-28
K941141 PRECISION OSTELOCK SP FEMORAL COMPONENT Howmedica Corp. LPH Class II 1994-09-28
K933275 P.F.C. CERAMIC HIP HEAD Johnson & Johnson Orthopaedics, Inc. LZO Class II 1994-09-28
K942834 ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA Acufex Microsurgical, Inc. HRX Class II 1994-09-28
K940290 ACUFEX ACL SHEATH FOR INTERFERENCE SCREWS Acufex Microsurgical, Inc. HRX Class II 1994-09-28
K942611 FOUNDATION ALL POLY CUP Encore Orthopedics, Inc. JDI Class II 1994-09-28
K942846 ACUFEX(R) ENDO-FEMORAL AIMER Acufex Microsurgical, Inc. HRX Class II 1994-09-28
K932837 CONSENSUS KNEE SYSTEM - PRIMARY KNEE U.S. Medical Products, Inc. JWH Class II 1994-09-27
K941486 INTEGRITY TOTAL HIP SYSTEM, NON-POROUS Kirschner Medical Corp. JDI Class II 1994-09-20
K942809 ACETABULAR DOME HOLE PLUGS Osteonics Corp. JDL Class III 1994-09-20
K942479 INTEGRAL CO-CR FEMORAL COMPONENT Biomet, Inc. JDG Class II 1994-09-20
K942028 RX90 FEMORAL COMPONENT Biomet, Inc. JDG Class II 1994-09-19
K941174 PIONEER LABORATORIES CABLE PIN Pioneer Surgical Technology HWC Class II 1994-09-19
K942027 IMPACT CO-CR 1-PIECE FEMORAL COMPONENT Biomet, Inc. JDG Class II 1994-09-19
K941273 INNOVASIVE ARTHROSCOPIC ROC SUTURE BONE FASTENER Innovasive Devices, Inc. HRX Class II 1994-09-16
K935617 ARTHRO-FLO IRRIGATION SYSTEM MODIFICATION Davol Inc., Sub. C. R. Bard, Inc. HRX Class II 1994-09-16
K940736 HAIG NAIL Howmedica Corp. JDS Class II 1994-09-12
K933108 TITAN TROCHANTERO-DIAHYSEAL TOTAL HIP PROSTHESIS Landos, Inc. LZO Class II 1994-09-12
K934166 NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION Corin Orthopedic Products JWH Class II 1994-09-07
K936079 ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT Exactech, Inc. JWH Class II 1994-09-07

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