meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
26
Latest Decision
1994-05-04

Clearances · page 148 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K934614 MINI FRAGMENT PLATE Onyx Medical Corp. HRS Class II 1994-05-04
K934169 FOUNDATION ALL POLY CUP Encore Orthopedics, Inc. JDI Class II 1994-05-03
K932687 AME(R) UNIVERSIAL CABLE SYSTEM American Medical Electronics, Inc. JDQ Class II 1994-05-03
K932923 IMPLEX A-230 POROUS ACETABULAR CUP SYST.CEMENTLESS Implex Corp. LPH Class II 1994-05-03
K931225 LOW PROFILE MID CROSS BRACING Advanced Spine Fixation Systems, Inc. KWP Class II 1994-05-02
K931642 RMHS MONOLITHIC FEMORAL COMPONENT Smith & Nephew Richards, Inc. LPH Class II 1994-04-29
K930891 SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST Synthes (Usa) KWP Class II 1994-04-29
K934765 TRILOGY ACETABULAR SYSTEM Zimmer, Inc. LPH Class II 1994-04-29
K934253 EXACTECH ALL POLY ACETABULAR CUP Exactech, Inc. JDZ Class I 1994-04-29
K935221 STRYKER ARTHROSCOPIC MANUAL SURGICAL INSTRUMENTS Stryker Endoscopy HRX Class II 1994-04-28
K934909 COBALT CHROME GEMINI Depuy, Inc. LWJ Class II 1994-04-28
K931323 MOUNTABLE KNIFE Esco Medical HRX Class II 1994-04-28
K931652 ACE 6.5 MM BONE SCREW Ace Medical Co. HWC Class II 1994-04-28
K936044 ENHANCED MODULAR AUSTIN MOORE HIP Zimmer, Inc. KMC Class II 1994-04-26
K940623 ACUFEX SURETAC IXC SYSTEMS Acufex Microsurgical, Inc. HRX Class II 1994-04-26
K932925 BONE ANCHOR FOR SOFT TISSUE ATTACHMENT Vesitec Medical, Inc. JDR Class II 1994-04-26
K940506 ACUFEX ARTHROSCOPIC SUTURE CUTTER Acufex Microsurgical, Inc. HRX Class II 1994-04-26
K930966 BAUMER PLATES Baumer Ortopedia , Ltd. HRS Class II 1994-04-25
K931679 BUTTRESS PLATE Onyx Medical Corp. HRS Class II 1994-04-25
K934353 ZIRCONIUM ALLOY UNI-POLAR HEAD Smith & Nephew Richards, Inc. KWL Class II 1994-04-25
K931694 1/4 TUBULAR PLATE Onyx Medical Corp. HRS Class II 1994-04-25
K931693 1/3 TUBULAR PLATE Onyx Medical Corp. HRS Class II 1994-04-25
K931681 CANNULATED NAVICULAR SCREW Onyx Medical Corp. HWC Class II 1994-04-25
K931683 CLOVERLEAF PLATE Onyx Medical Corp. HRS Class II 1994-04-25
K934616 CANCELLOUS BONE SCREW Onyx Medical Corp. HWC Class II 1994-04-25
K931687 MULTIPLE FRAGMENT PLATE Onyx Medical Corp. HRS Class II 1994-04-25
K934615 CANCELLOUS BONE SCREW Onyx Medical Corp. HWC Class II 1994-04-25
K931685 FOREARM SELF COMPRESSION PLATE Onyx Medical Corp. HRS Class II 1994-04-25
K931688 SEMI-TUBULAR PLATE Onyx Medical Corp. HRS Class II 1994-04-25
K931691 STRAIGHT MINI-PLATE Onyx Medical Corp. HRS Class II 1994-04-25
K931689 SMALL STRAIGHT PLATE Onyx Medical Corp. HRS Class II 1994-04-25
K931790 CORTICAL BONE SCREW Onyx Medical Corp. HWC Class II 1994-04-25
K933576 ARTHROSCOPE, DISPOSABLE United States Surgical, A Division of Tyco Healthc HRX Class II 1994-04-21
K931571 LINK CERAMIC HEADS 12/14 X 32MM Link America, Inc. LZO Class II 1994-04-19
K933203 APOLLO(TM) HIP SYST-STRAIGHT STEM/ALL-POLY ACET COMP Intermedics Orthopedics LZO Class II 1994-04-19
K941213 SONGER CABLE SYSTEM Pioneer Surgical Technology JDQ Class II 1994-04-19
K921119 ARTHREX ARTHROSCOPE Arthrex, Inc. HRX Class II 1994-04-15
K935836 BONE OR INTERFERENCE SCREW Endo Surgical Concepts, Inc. HWC Class II 1994-04-15
K935757 GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM Greenleaf Medical Systems, Inc. LBB Class II 1994-04-15
K934379 LINVATEC POWERLINK SURGICAL SHAVING SYSTEM Linvatec Corp. HRX Class II 1994-04-15
K940075 SHAVER BLADE SET Arthrex, Inc. HRX Class II 1994-04-15
K933787 POROCOAT POROUS COATING/AML PROXIMALLY-COATED STEM Depuy, Inc. LPH Class II 1994-04-13
K922613 CL HIP STEM H/A COATED Lima Intl. Corp. MEH Class II 1994-04-05
K931682 CANNULATED MALLEOLAR SCREW Onyx Medical Corp. KWK Class II 1994-04-05
K931686 MALLEOLAR SCREW Onyx Medical Corp. KTW Class II 1994-04-05
K931076 ARTHOSCOPE AND ACCESSORIES Meditron Devices, Inc. HRX Class II 1994-03-31
K922247 KINAMED REALITY TOTAL HIP SYSTEM Kinamed, Inc. LZO Class II 1994-03-30
K930969 BAUMER PINS Baumer Ortopedia , Ltd. HTY Class II 1994-03-29
K931109 NUCLEOTOME E KIT Surgical Dynamics, Inc. HRX Class II 1994-03-29
K930972 INTRAMEDULLARY SYSTEMS Baumer Ortopedia , Ltd. HSB Class II 1994-03-29
K931929 TECHMEDICA CONTINUUM HIP SYSTEM Techmedica, Inc. LZO Class II 1994-03-29
K922519 MOD. PERCUTANEOUS ARTHROSCOPIC MICRO DISCECTOMY Smith & Nephew, Inc. HRX Class II 1994-03-29
K914548 BRYAN SPINAL FIXATER (BSF) Arcan Orthopaedic Corp. KWP Class II 1994-03-28
K931208 LOW PROFILE SLEAVE NUT ASSEMBLY Advanced Spine Fixation Systems, Inc. KWP Class II 1994-03-28
K931572 LINK CERAMIC HEADS 14/16 X 32MM Link America, Inc. LZO Class II 1994-03-28
K931107 LOGYK ACETABULAR COMPONENT SYSTEM Arthronics, Inc. MBL Class II 1994-03-28
K933470 ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM Kinetix Instruments HRX Class II 1994-03-25
K934332 SURGICAL INSTRUMENTS, FORCEPS & GRASPERS, PROBES & CURETTES Friatec Medical Inc., USA HRX Class II 1994-03-25
K940454 GRASPING FORCEPS, PUNCHES, SCISSORS L.A.S.E.R., Inc. HRX Class II 1994-03-25
K932869 ARTHROPLANE Synvasive Technology, Inc. HRX Class II 1994-03-25
K934720 AUTO SUTURE DISPOSABLE ARTHROSCOPIC TROCAR AND SLEEVE United States Surgical, A Division of Tyco Healthc HRX Class II 1994-03-25
K933638 ACUMED CARPAL TUNNEL RELEASE KIT Acu Med, Inc. HRX Class II 1994-03-24
K934401 ARTHROTEK CANNULA SYSTEM Biomet, Inc. HRX Class II 1994-03-24
K933070 ARTHTOTEK PRECISION HAND INSTRUMENTATION Biomet, Inc. HRX Class II 1994-03-24
K940480 ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE Acufex Microsurgical, Inc. HTJ Class I 1994-03-23
K934181 ACUFEX ADJUSTABLE-LENGTH CANNULA Acufex Microsurgical, Inc. HRX Class II 1994-03-23
K936206 GORE SMOOTHER CRUCIAL TOOL W. L. Gore & Associates, Inc. HRX Class II 1994-03-23
K934962 AIM SUPRACONDYLAR NAIL Ace Orthopedic Manufacturing Co. HSB Class II 1994-03-22
K932460 ACUFEX MENISCAL RASPS Acufex Microsurgical, Inc. HRX Class II 1994-03-22
K934643 ACE HUMERAL NAIL Ace Orthopedic Manufacturing Co. HSB Class II 1994-03-22
K932718 ACUFEX METAL ACL CANNULA Acufex Microsurgical, Inc. HRX Class II 1994-03-21
K931641 POROCOAT POROUS COATING Depuy, Inc. LPH Class II 1994-03-21
K933949 DISPOSABLE ARTHROSCOPIC ACCESSORY United States Surgical, A Division of Tyco Healthc HRX Class II 1994-03-18
K922621 HA TI-FIT ACETABULAR AND FEMORAL COMPONENT Smith & Nephew Richards, Inc. MEH Class II 1994-03-17
K940286 GAMMA LOCKING NAIL MODIFICATION Howmedica, Inc. KTT Class II 1994-03-14
K933518 SYNTHES UNREAMED HUMERAL NAIL (URHN) Synthes (Usa) HSB Class II 1994-03-14
K930152 ARTHREX TIBIAL TUNNEL CANNULA Arthrex, Inc. HRX Class II 1994-03-11
K934161 PROFORM HIP SYSTEM Stelkast Company JDO Class II 1994-03-10
K932519 OSTEONICS(R) OMNIFIT(R) NORMALIZED HIP STEM Osteonics Corp. LZO Class II 1994-03-10
K932862 ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW Smith and Nephew Donjoy, Inc. HWC Class II 1994-03-10
K926395 ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM Depuy, Inc. LZO Class II 1994-03-10
K931588 SUTTER PROXIMAL INTERPHALANGEAL JOINT Sutter Corp. KYJ Class II 1994-03-10
K932574 RMHS POROUS DISTAL SLEEVE Smith & Nephew Richards, Inc. JDI Class II 1994-03-10
K932593 ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL Synthes (Usa) HSB Class II 1994-03-10
K934044 ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL INSTRUMENTATION SYSTEM Smith and Nephew Donjoy, Inc. HWC Class II 1994-03-10
K925460 SYNTHES STERILE PINLESS EXTERNAL FIXATOR Synthes (Usa) KTT Class II 1994-03-10
K925345 ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM) Biomet, Inc. LZO Class II 1994-03-10
K922796 PELVIC C-CLAMP Synthes (Usa) JEC Class II 1994-03-10
K935078 S-ROM TOTAL HIP REPLACEMENT SYSTEM Joint Medical Products Corp. JDG Class II 1994-03-09
K935950 FX-CABLELOK CABLE/PLATE SYSTEM Buckman Co., Inc. JDQ Class II 1994-03-09
K926156 REPLICA(TM) TOTAL HIP SYSTEM Osteo Technology, Inc. LPH Class II 1994-03-09
K935646 FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM Biodynamic Technologies, Inc. JDQ Class II 1994-03-09
K934162 PROFORM HA HIP SYSTEM Stelkast Company JDO Class II 1994-03-09
K933561 OSTEONICS OMNIFIT FORGED HIP STEM SERIES Osteonics Corp. JDI Class II 1994-03-09
K933359 OSTEONICS 22MM, +10 NECK BEARING HEADS Osteonics Corp. LWJ Class II 1994-03-07
K932174 GAMMA LOCKING NAIL-CROSS LOCKING SCREWS Howmedica Corp. KTT Class II 1994-03-07
K935012 BIOMETRIC TOTAL HIP SYSTEM Osteo-Technology Intl., Inc. JDI Class II 1994-03-07
K930967 BAUMER STAPLES Baumer Ortopedia , Ltd. JDR Class II 1994-03-07
K935731 ACETABULAR SHELL Howmedica Corp. LPH Class II 1994-03-03
K930187 OSTEONICS(R) ARC DEPOSITIONED FEMORAL COMPONENTS Osteonics Corp. JDI Class II 1994-03-03

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