meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
32
Latest Decision
2000-08-17

Clearances · page 126 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K001793 SYNTHES SCALLOPED DISTAL TIBIA PLATE Synthes (Usa) LXT Class II 2000-08-17
K002281 STELKAST PROVEN KNEE SYSTEM Stelkast Company JWH Class II 2000-08-17
K001580 GROSS FEMORAL COMPONENT Biomet, Inc. MEH Class II 2000-08-17
K002141 ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT Exactech, Inc. LWJ Class II 2000-08-16
K002008 SURGICAL DYNAMICS SPINAL RETRACTOR United States Surgical, A Division of Tyco Healthc HRX Class II 2000-08-16
K001706 WMT MODULAR SHOULDER SYSTEM Wrightmedicaltechnologyinc KWS Class II 2000-08-16
K001523 ULTIMA METAL-ON-METAL ACETABULAR CUP DePuy Orthopaedics, Inc. KWA Class III 2000-08-10
K001456 CONSENSUS KNEE SYSTEM Hayes Medical, Inc. JWH Class II 2000-08-07
K001471 THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ Implex Corp. LWJ Class II 2000-08-07
K984390 LACTOSORB PANELS AND FASTENERS Biomet, Inc. HRS Class II 2000-08-07
K991971 ARTHREX CHONDRAL DART, MODEL AR-4005B-18 Arthrex, Inc. HTY Class II 2000-08-04
K001470 E-Z LINK CROSS CONNECTOR Depuyacromed KWP Class II 2000-08-04
K001614 STRYKER TRAUMA PELVIC SET Howmedica Osteonics Corp. KTW Class II 2000-08-04
K001449 TRIDENT ACETABULAR SHELLS: PS Howmedica Osteonics Corp. LZO Class II 2000-08-04
K993166 STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM Stryker Endoscopy HWC Class II 2000-08-04
K000788 APEX MODULAR HIP STEM Apex Surgical, LLC LPH Class II 2000-08-04
K001571 BAUMER FEMORAL HEAD Baumer, S.A JDI Class II 2000-08-04
K001448 TRIDENT ACETABULAR SHELLS: PS-HA Howmedica Osteonics Corp. MEH Class II 2000-08-04
K001724 STIMULAN -CALCIUM SULFATE BONE VOID FILTER Biocomposites, Ltd. MQV Class II 2000-08-04
K994161 SYNTHES BIORESORBABLE SUTURE ANCHOR Synthes (Usa) MAI Class II 2000-07-28
K001378 BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736 Bionx Implants, Inc. MAI Class II 2000-07-28
K001419 SOLAR SHOULDER OFFSET HUMERAL HEAD Howmedica Osteonics Corp. HSD Class II 2000-07-27
K001536 INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS Sulzer Orthopedics, Inc. KWA Class III 2000-07-27
K001372 E-Z LINK CROSS CONNECTOR Depuyacromed KWP Class II 2000-07-27
K002106 NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER Biomet, Inc. JDI Class II 2000-07-27
K001745 MODIFICATION TO PROVIDENT HIP SYSTEM Stelkast Company LWJ Class II 2000-07-27
K001374 PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT Biomet Manufacturing, Inc. KRR Class II 2000-07-27
K001385 HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS Howmedica Osteonics Corp. KWI Class II 2000-07-27
K001350 PATIENT MATCHED TITANIUM ALLOY TROCHLEA Biomet, Inc. KRR Class II 2000-07-26
K001340 STACKABLE CAGE SYSTEM Depuyacromed MQP Class II 2000-07-26
K001982 TRI-LOCK HIP STEM DePuy Orthopaedics, Inc. LPH Class II 2000-07-26
K001989 COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES Zimmer, Inc. JDC Class II 2000-07-25
K001957 MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT Howmedica Osteonics Corp. KRO Class II 2000-07-25
K001942 SL-PLUS AND SLR-PLUS STEMS Plus Orthopedics LWJ Class II 2000-07-25
K994158 MACROSORBOS PROTECTIVE SHEET Macropore Biosurgery, Inc. HRS Class II 2000-07-24
K001864 SYNTHES CERVIFIX SYSTEM Synthes Spine KWQ Class II 2000-07-20
K001357 MODIFICATION TO OMEGA 21 SYSTEM Ebi, L.P. KWQ Class II 2000-07-20
K001932 TORNIER CEMENT RESTRICTOR Tornier JDI Class II 2000-07-20
K001376 TI-MAX PROTRUSIO CAGE Biomet, Inc. JDI Class II 2000-07-20
K001844 MODIFICATION TO CENTAUR SPINAL SYSTEM Howmedica Osteonics Corp. KWQ Class II 2000-07-19
K994214 GEM KNEE SYSTEM Kinamed, Inc. JWH Class II 2000-07-19
K001271 SAMARCO SPIDER PLATES Biomet, Inc. KTW Class II 2000-07-14
K001794 EBI ANTERIOR CERVICAL PLATE SYSTEM Ebi, L.P. KWQ Class II 2000-07-12
K001886 APEX FIXATION PINS Howmedica Osteonics Corp. JDW Class II 2000-07-12
K001255 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. MNH Class II 2000-07-11
K001231 THE KALIX IMPLANT New Deal, S.A. HWC Class II 2000-07-11
K001778 POROCOAT PRODIGY HIP PROSTHESIS DePuy Orthopaedics, Inc. LPH Class II 2000-07-07
K001320 SULZER ORTHOPEDICS INC. NATURAL-HIP SYSTEM LD STEM Sulzer Orthopedics, Inc. LPH Class II 2000-07-07
K001228 EXTERNAL FIXATION ANCHOR PIN Immedica, Inc. JDW Class II 2000-07-07
K983667 IONICS LEVANTE INTERVERTEBRAL PILLAR, EXPANDABLE Ionics Medical Corp. MQP Class II 2000-07-05
K001080 SPINE SYSTEM EVOLUTION Aesculap, Inc. KWP Class II 2000-06-29
K000683 MODIFIED SINGLE AXLE TOTAL ELBOW Biomet, Inc. JDC Class II 2000-06-27
K001226 SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM Smith & Nephew, Inc. HRX Class II 2000-06-26
K001277 TRIFLANGE ACETABULAR CUP SYSTEM DePuy Orthopaedics, Inc. LPH Class II 2000-06-23
K001078 SULZER ORTHOPEDICS MS-30 FEMORAL STEM Sulzer Orthopedics, Inc. JDI Class II 2000-06-23
K000827 UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED Walter Abendschein, M.D. KRR Class II 2000-06-23
K001066 CD HORIZON ECLIPSE Medtronic Sofamor Danek, Inc. MNH Class II 2000-06-22
K000978 ANATOMIC TOTAL KNEE PROSTHESIS Biomet, Inc. JWH Class II 2000-06-22
K994393 AEQUALIS UNIVERSAL SHOULDER GLENOID Tornier KWS Class II 2000-06-22
K001733 ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SYSTEM, MODEL 8011 SERIES & 1109 & 8109 SERIES Zimmer, Inc. JDI Class II 2000-06-20
K001559 CALCIUM SULFATE PELLETS Howmedica Osteonics Corp. MQV Class II 2000-06-20
K001311 SYNTHES (USA) ORIBITAL MESH PLATES Synthes (Usa) HRS Class II 2000-06-20
K994239 ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM Medtronic Sofamor Danek, Inc. KWQ Class II 2000-06-19
K001532 DYNA-LOK CLASSIC SPINAL SYSTEM Medtronic Sofamor Danek, Inc. KWP Class II 2000-06-16
K000972 SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS Synthes (Usa) LXT Class II 2000-06-16
K001039 THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP Implex Corp. LPH Class II 2000-06-15
K001084 TRANS FX ADJUSTABLE PIN TO BAR CLAMP Immedica, Inc. LXT Class II 2000-06-15
K001507 MICROPERFORATION INSTRUMENT Smith & Nephew, Inc. LXH Class I 2000-06-14
K001660 MALLORY HEAD MODULAR CALCAR Biomet Orthopedics, Inc. LPH Class II 2000-06-14
K001534 PINNACLE ACETABULAR SYSTEM DePuy Orthopaedics, Inc. LPH Class II 2000-06-12
K993335 SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM Synthes (Usa) HTO Class I 2000-06-12
K000817 OMEGA II MODULAR TOTAL HIP SYSTEM Osteoimplant Technology, Inc. JDI Class II 2000-06-08
K001046 BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS Biopro, Inc. KWS Class II 2000-06-08
K993066 WINDOW CERVICAL DYNAMIC PLATE SYSTEM Advanced Spine Technology, Inc. KWQ Class II 2000-06-07
K001548 MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS Howmedica Osteonics Corp. KRO Class II 2000-06-07
K993874 BOFOR REVISION COUP Plus Orthopedics LZO Class II 2000-06-05
K001627 TRIFIX SPINAL FIXATION SYSTEM Endius, Inc. MNH Class II 2000-06-03
K000766 TRI-FIX SPINAL FIXATION SYSTEM Endius, Inc. MNI Class II 2000-06-01
K000957 HOFFMANN II EXTERNAL FIXATION SYSTEM Howmedica Osteonics Corp. LXT Class II 2000-05-23
K994350 NEER III TOTAL SHOULDER SYSTEM Smith & Nephew, Inc. KWS Class II 2000-05-23
K000760 REACH FEMORAL COMPONENT Biomet, Inc. LPH Class II 2000-05-23
K001024 PASS SPINAL SYSTEM Encore Orthopedics, Inc. MNH Class II 2000-05-23
K001358 EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM Ebi, L.P. KTT Class II 2000-05-23
K001307 CONTINUUM KNEE SYSTEM-PS FEMORAL COMPONENTS- POROUS, MODEL XX-YYY-ZZZZZ Implex Corp. JWH Class II 2000-05-23
K001319 XIA SPINE SYSTEM HOOKS Howmedica Osteonics Corp. MNH Class II 2000-05-23
K993438 METAL ON METAL ACETABULAR SYSTEM Biomet, Inc. KWA Class III 2000-05-18
K001335 ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED Exactech, Inc. JDI Class II 2000-05-18
K001451 MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS DePuy Orthopaedics, Inc. HRY Class II 2000-05-18
K000965 MULTI-AXIAL CROSS (MAC) CONNECTOR Howmedica Osteonics Corp. MNI Class II 2000-05-11
K000694 PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF) Pectofix, Inc. JDQ Class II 2000-05-11
K000658 ERS RADIAL HEAD REPLACEMENT DePuy Orthopaedics, Inc. KWI Class II 2000-05-11
K000590 LATERAL PIVOT INSERT Encore Orthopedics, Inc. JWH Class II 2000-05-11
K001272 XIA SPINE SYSTEM Howmedica Osteonics Corp. KWQ Class II 2000-05-11
K000636 STRYKER TRAUMA PLATING SYSTEM Howmedica Osteonics Corp. HRS Class II 2000-05-11
K991031 COLORADO II SPINAL SYSTEM Sofamor Danek USA,Inc. MNH Class II 2000-05-10
K000521 KEYSTONE HIP Encore Orthopedics, Inc. LPH Class II 2000-05-10
K000734 PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601 Pioneer Surgical Technology KTT Class II 2000-05-05
K000691 VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELS Oratec Interventions, Inc. HRX Class II 2000-05-04
K994126 MODULAR-PLUS REVISION STEM Plus Orthopedics LWJ Class II 2000-05-04
K000682 SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM Synthes (Usa) KTT Class II 2000-05-01

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