meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
29
Latest Decision
1995-06-14

Clearances · page 144 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K951354 OLYMPUS ARTHROSCOPY SYSTEM Olympus America, Inc. HRX Class II 1995-06-14
K930298 ROGOZINSKI SPINAL ROD SYSTEM SCREW Smith & Nephew Richards, Inc. MNH Class II 1995-06-14
K945684 POC ARTHROSCOPE AND ACCESSORIES Precision Optics Corp. HRX Class II 1995-06-14
K934590 IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS Smith & Nephew Richards, Inc. HWC Class II 1995-06-14
K945787 KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ENDOSCOPIC ARTHROSCOPY PROCEDURES KARL STORZ Endoscopy-America, Inc. HRX Class II 1995-06-13
K944500 ACUFEX PATELLAR BONE BLOCK SIZER Acufex Microsurgical, Inc. HRX Class II 1995-06-12
K945137 LUHR TITANIUM ALLOY PAN FIXATION SYSTEM Howmedica Corp. HRS Class II 1995-06-12
K943354 SUTTER HAMMERTOE JOINT PROSTHESIS Sutter Corp. KWH Class II 1995-06-12
K945139 LUHR TITANIUM PAN FIXATION SYSTEM Howmedica Corp. HRS Class II 1995-06-12
K945891 KARL STORZ KNIVES, CURETTS, HOOKS, PROBES KARL STORZ Endoscopy-America, Inc. HRX Class II 1995-06-09
K951859 ACUFEX ENDOBUTTON PACK Acufex Microsurgical, Inc. HRX Class II 1995-06-09
K952192 KARL STORZ UNIDRIVE SHAVER, ARTHROSCOPY BLADES KARL STORZ Endoscopy-America, Inc. HRX Class II 1995-06-08
K940715 OSTEONICS OMNIFIT AD HIP STEM SERIES Osteonics Corp. LPH Class II 1995-06-07
K936310 ORTHOMET HMC FEMORAL STEM COMPONENT Orthomet, Inc. LPH Class II 1995-06-07
K950563 ULTIMA AUGMENTED UHMWPE CUP Johnson & Johnson Professionals, Inc. KWL Class II 1995-06-07
K941366 OSTEONICS OMNIFIT AD-HA HIP STEM SERIES Osteonics Corp. MEH Class II 1995-06-06
K935523 NATURAL-KNEE(R)/APOLLO(TM) KNEE Intermedics Orthopedics JWH Class II 1995-06-06
K951026 DAVOL ARTHRO-FLO 3 Davol Inc., Sub. C. R. Bard, Inc. HRX Class II 1995-06-02
K950592 ACCESSORIES FOE ORTHOPEDIC SURGICAL PROCEDURES Eare Consulting Service HRX Class II 1995-06-01
K951163 GORE SMOOTHER GUIDED RASP W. L. Gore & Associates, Inc. HRX Class II 1995-06-01
K945435 BRYAN POSTERIOR SPINAL FIXATOR (BPSF) Arcan Orthopaedic Corp. KWP Class II 1995-05-31
K951084 S-ROM OPC (ONE-PIECE CEMENTED) II FEMORAL HIP PROSTHESIS Joint Medical Products Corp. JDI Class II 1995-05-31
K945589 CONSENSUS(TM) KNEE COBALT CHROME NONPOROUS STEMMED TIBIAL BASEPLATE U.S. Medical Products, Inc. JWH Class II 1995-05-31
K945574 OSTEONICS(R) CCR HIP STEM SERIES Osteonics Corp. JDI Class II 1995-05-30
K943908 INFINITY SHOULDER SYSTEM Wrightmedicaltechnologyinc HSD Class II 1995-05-30
K945783 ORTHOMET TITANIUM HYBRID FEMORAL STEM Orthomet, Inc. JDG Class II 1995-05-30
K950651 TOTAL SHOULDER PROSTHESIS Encore Orthopedics, Inc. KWS Class II 1995-05-30
K944756 ISOLA OPEN AND CLOSED SCREWS Acromed Corp. MNH Class II 1995-05-30
K943950 ETHICON NONABSORBABLE SUTURE ANCHOR ETHICON, Inc. JDR Class II 1995-05-30
K945844 DEPUY CDH PROSTHESIS Depuy, Inc. MEH Class II 1995-05-25
K951355 LINK SADDLE PROTHESIS Turnkey Intergration USA, Inc. KWL Class II 1995-05-25
K943052 ARTHROSCOPIC TELESCOPES Karl Storz Endoscopy HRX Class II 1995-05-25
K950542 METAL BACKED ACETABULAR COMPONENT Encore Orthopedics, Inc. JDL Class III 1995-05-25
K946165 CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM Elekta Instruments, Inc. HRS Class II 1995-05-23
K945267 OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES Optus, Inc. HRX Class II 1995-05-23
K940179 ARTHROSCOPE FOR SMALL JOINT AFTER FELDKAMP, MODEL 8871.011 Richard Wolf Medical Instruments Corp. HRX Class II 1995-05-23
K950384 SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR Synthes (Usa) LXT Class II 1995-05-22
K935802 SELECT(R) SHOULDER ALL POLY GLENOID Intermedics Orthopedics KWS Class II 1995-05-22
K950594 HEMI-SHOULDER PROSTHESIS Encore Orthopedics, Inc. HSD Class II 1995-05-22
K936159 NATURAL-KNEE II SYSTEM Intermedics Orthopedics JWH Class II 1995-05-22
K951083 PROFORM CEMENTED FEMORAL COMPONENT Stelkast Company JDG Class II 1995-05-22
K950070 MITEK TOGGLE ANCHOR(TM) Mitek Surgical Products, Inc. JDR Class II 1995-05-22
K931265 FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND Ferguson Medical JWI Class II 1995-05-22
K935080 INSALL-BURSTEIN II Hospital For Special Surgery JWH Class II 1995-05-22
K950394 TIBIA-TALUS-CALCANEUS NAIL Smith & Nephew Richards, Inc. HSB Class II 1995-05-19
K944592 PRECISION OSTEOLOCK FEMORAL COMPONENT Howmedica Corp. LPH Class II 1995-05-17
K950250 MED-SURG SUTURE WASHER Medical Surgical, Inc. HWC Class II 1995-05-17
K943696 ALL POLYETHYLENE CEMENTED ACETABULAR CUP Depuy, Inc. JDI Class II 1995-05-17
K950312 ALPHA SYSTEM Zimmer, Inc. JDI Class II 1995-05-17
K944856 ORTHOMET ACETABULAR ROOF REINFORCEMENT RING Wrightmedicaltechnologyinc HRS Class II 1995-05-16
K943929 DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS) Greenleaf Medical Systems, Inc. KQX Class I 1995-05-15
K950202 RINGLOC CONSTRAINED LINER Biomet, Inc. KWZ Class II 1995-05-15
K950010 DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED Johnson & Johnson Professionals, Inc. JWH Class II 1995-05-15
K946228 CROSS PIN SCREW SYSTEM Depuy, Inc. JDW Class II 1995-05-15
K950242 ARGUS ARTHROSCOPY INSTRUMENT SYSTEM Argus Medical Co., Inc. HRX Class II 1995-05-15
K945022 APOFIX CERVICAL SPINE FIXATION Sofamor Co. KWP Class II 1995-05-15
K950501 DANEK RIGID ARTHROSCOPE Sofamor Danek USA,Inc. HRX Class II 1995-05-12
K950561 KSEA DISPOSABLE TUBING SET FOR THE ARTHROPUMP KARL STORZ Endoscopy-America, Inc. HRX Class II 1995-05-12
K951674 DEPUY DURALOC 100C ACETABULAR CUP Depuy, Inc. LPH Class II 1995-05-11
K945630 LARGE MUSCLE STRENGTH GAUGE J-Tech, Inc. KQX Class I 1995-05-10
K934321 LINVATEC STASYS-PES FIXATION DEVICE Linvatec Corp. HWC Class II 1995-05-10
K950618 ACE SUPRACONDYLAR PLATE Ace Medical Co. HRS Class II 1995-05-10
K943356 INCLUSIVE ENDOSCOPE Danek Medical, Inc. HRX Class II 1995-05-10
K946151 BENCHMARK SERIES ARTHROSCCOPIC INSTRUMENTS Depuy, Inc. HRX Class II 1995-05-09
K950705 1.2MM DISPOSABLE NEUROVIEW PREFORMED ENDOSCOPE Neuro Navigational Corp. HRX Class II 1995-05-09
K951302 SMALL FRAGMENT PLATES AND SCREWS Medpac JDS Class II 1995-05-05
K944736 VSP (VARIABLE SCREW PLACEMENT) Acromed Corp. MNH Class II 1995-05-05
K944330 ACUTRAK PLUS FIXATION SYSTEM Acu Med, Inc. HWC Class II 1995-05-05
K946156 DEPUY COMPRESSION HIP SCREW SYSTEM Depuy, Inc. KTT Class II 1995-05-03
K945115 MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS Biomet, Inc. JDI Class II 1995-05-02
K940483 2.3 MM DISPOSABLE NEUROVIEW ENDOSCOPE Neuro Navigational Corp. HRX Class II 1995-05-02
K950761 INDEX ACETABULAT COMPONENT Biomet, Inc. JDI Class II 1995-05-02
K950130 MICRO-ENDO(TM) INSTRUMENTS Sofamor Danek USA,Inc. HRX Class II 1995-05-01
K951095 10.5MM REPLICA HIP STEM Depuy, Inc. LPH Class II 1995-04-27
K943873 ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY Orthomet, Inc. LXH Class I 1995-04-26
K944792 ZIMMER MONOBLOC HIP PROSTHESIS WITH POLY (METHYL METHACRYLATE) Zimmer, Inc. JDI Class II 1995-04-26
K943775 SELBY INSTRUMENTATION Advanced Spine Fixation Systems, Inc. MNH Class II 1995-04-26
K945064 SELBY INSTRUMENTATION Advanced Spine Fixation Systems, Inc. MNH Class II 1995-04-26
K946346 ACUFEX TAG(R) BIOABSORBABLE ANCHORS Acufex Microsurgical, Inc. JDR Class II 1995-04-26
K941188 CLARUS NEURO ENDOSCOPE (MODEL 2230) Clarus Medical Systems, Inc. HRX Class II 1995-04-25
K940144 CLARUS PHOENIX ENDOSCOPE Clarus Medical Systems, Inc. HRX Class II 1995-04-25
K950827 PROFORM POROUS ACETABULAR ASSEMBLY Stelkast Company LPH Class II 1995-04-18
K951301 DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM Depuy, Inc. LPH Class II 1995-04-18
K951000 ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM Joint Medical Products Corp. LPH Class II 1995-04-14
K941709 ACUFEX ARTHROSCOPIC DISCECTOMY SYSTEMS Acufex Microsurgical, Inc. HRX Class II 1995-04-14
K945426 ARTHREX CANCELLOUS SCREW AND WASHER Arthrex, Inc. HWC Class II 1995-04-14
K945639 SPETZLER PIN Howmedica Corp. HTY Class II 1995-04-14
K942359 BONE PLATE SYSTEM Acu Med, Inc. HRS Class II 1995-04-13
K950998 MODUILAR UNIPOLAR Intermedics Orthopedics KXA Class II 1995-04-13
K944188 SPINAL MARKER Leibinger L.P. LXH Class I 1995-04-13
K946234 OSTEONICS(R) RESTORATION MONOLITHIC II HIP STEM SERIES Osteonics Corp. MEH Class II 1995-04-10
K945793 P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR Johnson & Johnson Professionals, Inc. KWY Class II 1995-04-10
K950115 LUHR(R) TITANIUM BURR HOLE COVERS Howmedica, Inc. HRS Class II 1995-04-10
K944836 OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES Osteonics Corp. MEH Class II 1995-04-10
K950105 LUHR(R) TITANIUM ALLOY BURR HOLE COVERS Howmedica Corp. HRS Class II 1995-04-10
K940328 PRIME CEMENTED HIP SYSTEM Orthopaedic Innovations, Inc. JDI Class II 1995-04-07
K946371 PROVIDENT HP SYSTEM Stelkast Company JDI Class II 1995-04-05
K944092 ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM Orthofix Srl JEC Class II 1995-04-04
K935449 FOUNDATION NON-POROUS STEM Encore Orthopedics, Inc. JDI Class II 1995-03-30
K944936 MITEK G III ANCHOR, MITEK LS ANCHOR Mitek Surgical Products, Inc. JDR Class II 1995-03-24

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