Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 29
- Latest Decision
- 2000-05-01
Clearances · page 127 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K000506 | BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B | Arthrex, Inc. | MAI | Class II | 2000-05-01 |
| K000684 | SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM | Synthes (Usa) | KTT | Class II | 2000-04-28 |
| K001010 | ASCENT KNEE REVISION FEMORAL STEM | Biomet, Inc. | JWH | Class II | 2000-04-27 |
| K993513 | DELTALOC ANTERIOR CERVICAL PLATE SYSTEM | Alphatec Mfg., Inc. | KWQ | Class II | 2000-04-26 |
| K993630 | BIOLOK SCREW | Encore Orthopedics, Inc. | HWC | Class II | 2000-04-26 |
| K000392 | RESPONSE 2000 HIP STEM | DePuy Orthopaedics, Inc. | LZO | Class II | 2000-04-24 |
| K001105 | MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS | Depuyacromed | KWP | Class II | 2000-04-24 |
| K000432 | RESPONSE 2000 CEMENTED HIP STEM | DePuy Orthopaedics, Inc. | LZO | Class II | 2000-04-24 |
| K000991 | MODIFICATION TO TSRH SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | MNI | Class II | 2000-04-18 |
| K000876 | SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR ROD, SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR LAMP | Interpore Cross Intl. | MNI | Class II | 2000-04-18 |
| K000486 | ABC CERVICAL PLATING SYSTEM | Aesculap, Inc. | KWQ | Class II | 2000-04-14 |
| K993503 | HAIDER-UCR SPINAL SYSTEM | International Advanced Medical Enterprises, Inc. | MNH | Class II | 2000-04-14 |
| K001037 | MODIFICATION TO EBI SPINELINK SYSTEM | Ebi, L.P. | MNI | Class II | 2000-04-14 |
| K000558 | SYNTHES (USA) WRIST FUSION PLATES (WFP) | Synthes (Usa) | LXT | Class II | 2000-04-14 |
| K990830 | MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS | Biomet, Inc. | LPH | Class II | 2000-04-11 |
| K000198 | CORTEK ARTHROSCOPE | Cortek Endoscopy, Inc. | HRX | Class II | 2000-04-11 |
| K994288 | 5.0MM SPINAL SCREWS | Ortho Tec, LLC | MNH | Class II | 2000-04-10 |
| K000321 | HEMISPHERE MODULAR CUP SYSTEM | Ortho Development Corp. | LPH | Class II | 2000-04-10 |
| K992154 | BICON-PLUS ACETABULAR COMPONENTS | Plus Orthopedics | LPH | Class II | 2000-04-06 |
| K993027 | ESKA MODULAR HIP SYSTEM | Specs USA, Inc. | LPH | Class II | 2000-04-06 |
| K000764 | PEDIATRIC FIXATION RODS | Biomet, Inc. | JDS | Class II | 2000-04-06 |
| K983657 | OSTEONICS SERIES 7000 AD TIBIAL TRAY | Osteonics Corp. | HRY | Class II | 2000-04-06 |
| K000113 | PROVEN KNEE SYSTEM | Stelkast Company | JWH | Class II | 2000-04-04 |
| K000080 | ASNIS III CANNULATED SCREW SYSTEM | Howmedica Osteonics Corp. | HWC | Class II | 2000-04-03 |
| K000797 | OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01 | Orthopaedic Biosystems, Ltd. | JDR | Class II | 2000-04-03 |
| K000262 | BOHN FEMORAL COMPONENT | Biomet Manufacturing, Inc. | MEH | Class II | 2000-04-03 |
| K000046 | KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS) | Richard Wolf Medical Instruments Corp. | HRX | Class II | 2000-03-30 |
| K984360 | COLORADO II SPINAL SYSTEM | Sofamor Danek USA,Inc. | MNH | Class II | 2000-03-30 |
| K000742 | SYNTHES ANTERIOR CSLP SYSTEM | Synthes Spine | KWQ | Class II | 2000-03-29 |
| K000019 | SINGLE SIZE TENDON SPACER | Medist International | HXA | Class II | 2000-03-29 |
| K994370 | ORTHO DEVELOPMENT BALANCED KNEE SYSTEM | Ortho Development Corp. | JWH | Class II | 2000-03-24 |
| K000616 | SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828 | Bionx Implants, Ltd. | MAI | Class II | 2000-03-23 |
| K000306 | PINNACLE ACETABULAR SYSTEM | DePuy Orthopaedics, Inc. | LPH | Class II | 2000-03-23 |
| K994366 | TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM | Howmedica Osteonics Corp. | MEH | Class II | 2000-03-16 |
| K000536 | SYNTHES ANTERIOR CSLP SYSTEM | Synthes Spine | KWQ | Class II | 2000-03-15 |
| K994347 | CENTAUR SPINAL SYSTEM | Howmedica Osteonics Corp. | KWQ | Class II | 2000-03-15 |
| K000538 | MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL | Biomet, Inc. | LPH | Class II | 2000-03-15 |
| K994364 | SYNTHES BUTTON PLATE | Synthes (Usa) | MBI | Class II | 2000-03-15 |
| K000066 | SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM | Synthes (Usa) | HRS | Class II | 2000-03-15 |
| K994207 | HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE | Howmedica Osteonics Corp. | KRO | Class II | 2000-03-13 |
| K000009 | SPIRAL RADIUS RODDING SYSTEM | United States Surgical, A Division of Tyco Healthc | KWQ | Class II | 2000-03-10 |
| K000450 | MODIFICATION TO SYNTHES USS | Synthes Spine | MNI | Class II | 2000-03-10 |
| K994382 | NONLINEAR TAPER LAG SCREW | Theken Surgical | HWC | Class II | 2000-03-10 |
| K992850 | MAGELLAN TIBIAL INTRAMEDULLARY NAIL | Orthomatrix, Inc. | HSB | Class II | 2000-03-10 |
| K994286 | ZMR HIP SYSTEM-POROUS REVISION | Zimmer, Inc. | LPH | Class II | 2000-03-10 |
| K000476 | MODIFICATION TO CD SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | MNH | Class II | 2000-03-10 |
| K992856 | MAGELLAN HUMERAL INTRAMEDULLARY NAIL | Orthomatrix, Inc. | HSB | Class II | 2000-03-10 |
| K000091 | DURACON SYMMETRIC METAL-BACKED PATELLAR COMPONENT | Howmedica Osteonics Corp. | JWH | Class II | 2000-03-10 |
| K000453 | MODIFICATION TO CD SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | MNH | Class II | 2000-03-10 |
| K993259 | INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS | Sulzer Orthopedics, Inc. | LPH | Class II | 2000-03-10 |
| K000575 | GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD | DePuy Orthopaedics, Inc. | KWS | Class II | 2000-03-10 |
| K994392 | AEQUALIS SHOULDER FRACTURE SYSTEM | Tornier | KWS | Class II | 2000-03-10 |
| K000634 | ROD TO ROD CROSS BRACES | Corin USA | KWQ | Class II | 2000-03-10 |
| K000513 | MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM | Ebi, L.P. | KWQ | Class II | 2000-03-07 |
| K000425 | ISOBAR SPINAL SYSTEM | Encore Orthopedics, Inc. | MNI | Class II | 2000-03-07 |
| K994152 | THE LIGAMENT ANCHOR SOFT SCREW | Corin USA | HWC | Class II | 2000-03-06 |
| K994128 | SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEM | Howmedica Osteonics Corp. | JWH | Class II | 2000-03-06 |
| K994363 | INSTRUMENTS FOR MINIMALLY INVASIVE SPINAL SURGERY (MISS) | Richard Wolf Medical Instruments Corp. | HRX | Class II | 2000-03-06 |
| K990330 | CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ | Implex Corp. | JDI | Class II | 2000-03-01 |
| K000279 | STAPLETAC2 BONE ANCHOR SYSTEM | American Medical Systems, Inc. | MBI | Class II | 2000-03-01 |
| K994232 | PHALANGEAL FIXATION SYSTEM | Medcanica, Inc. | HTY | Class II | 2000-03-01 |
| K994217 | BLACKSTONE SPINAL FIXATION SYSTEM | Blackstone Medical, Inc. | MNH | Class II | 2000-02-28 |
| K992147 | TRIPLE-FIX SPINAL FIXATION SYSTEM | Advanced Spine Technology, Inc. | MNI | Class II | 2000-02-28 |
| K994153 | CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS | Corin USA | KXA | Class II | 2000-02-25 |
| K000232 | ROTAGLIDE + MODULAR KNEE SYSTEM WITH FIXED MENISCUS | Corin USA | JWH | Class II | 2000-02-25 |
| K992220 | RADIAL HEAD PROSTHESIS | Smith & Nephew, Inc. | KWI | Class II | 2000-02-25 |
| K000319 | EBI XFIX DFS SYSTEM | Ebi, L.P. | KTT | Class II | 2000-02-25 |
| K000335 | MALLORY-HEAD MODULAR CALCAR TOTAL HIP SYSTEM | Biomet, Inc. | LPH | Class II | 2000-02-25 |
| K993714 | MEMOGRAPH STAPLE, WARM SYSTEM | Biomedical Ent., Inc. | JDR | Class II | 2000-02-25 |
| K994202 | ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM | Smith & Nephew, Inc. | HWC | Class II | 2000-02-25 |
| K992359 | MRS-TITAN | Rotec Medizintechnik GmbH | LZO | Class II | 2000-02-18 |
| K994143 | SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES] | Smith & Nephew, Inc. | JDW | Class II | 2000-02-18 |
| K994122 | BONE GRAFT WASHER, MODEL 9090114 - 9090118 | Danek Medical, Inc. | KWQ | Class II | 2000-02-18 |
| K994076 | IMPLEX HEDROCEL PS TIBIAL COMPONENT, MODEL HEDROCEL POSTERIOR STABILIZED TIBIAL COMPONENT 05-XXX-YYYYY | Implex Corp. | JWH | Class II | 2000-02-18 |
| K994425 | MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM | Endius, Inc. | HRX | Class II | 2000-02-16 |
| K000236 | SYNERGY VLS CAP NUT MODELS 2206, 6102 | Interpore Cross Intl. | MNI | Class II | 2000-02-16 |
| K000334 | IMPACT MODULAR TOTAL HIP SYSTEM | Biomet, Inc. | LPH | Class II | 2000-02-16 |
| K000242 | ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE | Exactech, Inc. | MEH | Class II | 2000-02-16 |
| K994184 | PLR SPLINED REVISION STEM | Biomet, Inc. | LZO | Class II | 2000-02-15 |
| K994061 | LOCON-T DISTAL RADIAL PLATE | Wrightmedicaltechnologyinc | HRS | Class II | 2000-02-14 |
| K993903 | WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013 | Whiteside Biomechanics, Inc. | JDQ | Class II | 2000-02-14 |
| K993889 | EXETER CERAMIC FEMORAL HEADS | Howmedica Osteonics Corp. | LZO | Class II | 2000-02-11 |
| K992739 | CLICK'X | Synthes Spine | MNH | Class II | 2000-02-08 |
| K000153 | ARTHRO-SURGIMAT-A103 | W.O.M. World of Medicine GmbH | HRX | Class II | 2000-02-08 |
| K000094 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | MNH | Class II | 2000-02-08 |
| K992815 | THE MARGRON HIP REPLACEMENT SYSTEM | Portland Orthopaedics Pty. , Ltd. | MEH | Class II | 2000-02-07 |
| K000254 | PAR 5 ACETABULAR COMPONENT | Biomet, Inc. | JDI | Class II | 2000-02-07 |
| K994383 | DOGBONE ACFS | Theken Surgical | KWQ | Class II | 2000-02-04 |
| K994007 | MALLORY/HEAD SMOOTH FEMORAL COMPONENT | Biomet, Inc. | JDI | Class II | 2000-02-04 |
| K993943 | ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA, ENCORE REVELATION POROUS HIP WITH HA | Encore Orthopedics, Inc. | MEH | Class II | 2000-02-04 |
| K000207 | POROCOAT PRODIGY HIP PROSTHESIS | DePuy Orthopaedics, Inc. | LPH | Class II | 2000-02-04 |
| K992012 | WILTSE SYSTEM | Advanced Spine Fixation Systems, Inc. | KWQ | Class II | 2000-02-04 |
| K993762 | I.CO.S SCREW | New Deal, S.A. | HWC | Class II | 2000-02-04 |
| K992525 | ACUMED MODULAR SHOULDER SYSTEM | Acu Med, Inc. | HSD | Class II | 2000-02-04 |
| K000089 | SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS | Synthes (Usa) | HWC | Class II | 2000-02-03 |
| K000020 | MODIFICATION TO ISOBAR SPINAL SYSTEM | Encore Orthopedics, Inc. | MNH | Class II | 2000-02-03 |
| K000083 | EBI XFIX DFS RAIL SYSTEM | Ebi, L.P. | KTT | Class II | 2000-02-03 |
| K994415 | MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS | DePuy Orthopaedics, Inc. | LPH | Class II | 2000-02-03 |
| K993810 | CD HORIZON SPINAL SYSTEM | Danek Medical, Inc. | MNH | Class II | 2000-02-03 |
| K000172 | DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS | DePuy Orthopaedics, Inc. | HRY | Class II | 2000-02-03 |
17,115 clearances in the Orthopedic panel. Data: openFDA.