Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 29
- Latest Decision
- 2001-12-20
Clearances · page 121 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K011139 | LORENZ LACTOSORB PANELS AND FASTENERS | Biomet, Inc. | HRS | Class II | 2001-12-20 |
| K013989 | ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER | Smith & Nephew, Inc. | LZO | Class II | 2001-12-19 |
| K013616 | POLARUS CAP SCREW | Acu Med, Inc. | HSB | Class II | 2001-12-19 |
| K013248 | SYNTHES LCP DISTAL TIBIA PLATES | Synthes (Usa) | HRS | Class II | 2001-12-19 |
| K013449 | MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM | Disc-O-Tech Medical Technologies, Ltd. | HSB | Class II | 2001-12-19 |
| K013823 | XIA SPINAL SYSTEM | Howmedica Osteonics Corp. | KWP | Class II | 2001-12-19 |
| K013877 | CODMAN SLIM-LOC SYSTEM | Codman & Shurtleff, Inc. | KWQ | Class II | 2001-12-19 |
| K013553 | PRE-LOADED ULTRAFIX RC | Linvatec Corp. | MBI | Class II | 2001-12-19 |
| K993836 | GENERATION 4 BONE CEMENT | Biomet, Inc. | LOD | Class II | 2001-12-19 |
| K013430 | ACE BIO WIN TIBIAL NAILING SYSTEM | DePuy Orthopaedics, Inc. | HSB | Class II | 2001-12-17 |
| K013903 | HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2 | Triad Medical, Inc. | HWC | Class II | 2001-12-17 |
| K013786 | DRG ORTHOHEX SS BONE SCREW | Doctor'S Research Group, Inc. | HWC | Class II | 2001-12-17 |
| K013352 | SUMMIT CEMENTED HIP PROSTHESIS | DePuy Orthopaedics, Inc. | JDI | Class II | 2001-12-17 |
| K013534 | SELF-COUNTERSINKING BONE SCREW | Biomet Orthopedics, Inc. | HWC | Class II | 2001-12-17 |
| K012378 | 3D HUMERAL HEADS | Smith & Nephew, Inc. | KWS | Class II | 2001-12-13 |
| K013334 | ENDOFLIP | Arthocare Corporation | MBI | Class II | 2001-12-13 |
| K013935 | ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS | Sulzer Orthopedics, Inc. | LZO | Class II | 2001-12-13 |
| K011454 | SPINE SCOPE, MODEL 2180 | Clarus Medical, LLC | HRX | Class II | 2001-12-13 |
| K013739 | MODIFICATION TO EBI XFIX DFS SYSTEM | Ebi, L.P. | LXT | Class II | 2001-12-13 |
| K013890 | SURGICAL DYNAMICS MENISCAL STAPLE | United States Surgical, A Division of Tyco Healthc | HWC | Class II | 2001-12-11 |
| K012762 | MJS POSTERIOR STABILIZED KNEE SYSTEM | Osteoimplant Technology, Inc. | HRY | Class II | 2001-12-11 |
| K011451 | REUNITE FUSION SCREW | Biomet, Inc. | HWC | Class II | 2001-12-10 |
| K013035 | GUARDIAN LIMB SALVAGE SYSTEM | Wrightmedicaltechnologyinc | KRO | Class II | 2001-12-07 |
| K013031 | MOST OPTIONS SYSTEM | Sulzer Orthopedics, Inc. | KRO | Class II | 2001-12-07 |
| K003324 | PLASMA SPRAYED SHOULDER | Encore Orthopedics, Inc. | KWS | Class II | 2001-12-06 |
| K013818 | AUTOGENESIS AUTOMATOR, MODEL M1000 | Autogenesis, Inc. | JEC | Class II | 2001-12-05 |
| K013688 | MODIFICATION TO XIA SPINAL SYSTEM | Howmedica Osteonics Corp. | MNH | Class II | 2001-12-05 |
| K013676 | TRIDENT HEMISPHERICAL ACETABULAR SHELLS | Howmedica Osteonics Corp. | MEH | Class II | 2001-12-05 |
| K013658 | MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS | Smith & Nephew, Inc. | LPH | Class II | 2001-12-05 |
| K013211 | MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS | Exactech, Inc. | KWY | Class II | 2001-12-05 |
| K013657 | MODIFICATION TO: BIOMET HUMERAL CABLE PLATES | Biomet Orthopedics, Inc. | HRS | Class II | 2001-12-03 |
| K012945 | SYNTHES 2.4 MM CANNULATED SCREW | Synthes (Usa) | HWC | Class II | 2001-12-03 |
| K012572 | SOFT TISSUE SCREW AND WASHER | Biomet, Inc. | HWC | Class II | 2001-12-03 |
| K013044 | SYNTHES 3.9 MM PELVIC SCREWS | Synthes (Usa) | HWC | Class II | 2001-12-03 |
| K013772 | MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM | Howmedica Osteonics | LXT | Class II | 2001-12-03 |
| K012469 | RESORBABLE NO PROFILE SCREW AND WASHER | Biomet Manufacturing, Inc. | HWC | Class II | 2001-12-03 |
| K013117 | RESECTION ABLATOR | Linvatec Corp. | HRX | Class II | 2001-11-29 |
| K012916 | FRONTIER ANTERIOR SCOLIOSIS SYSTEM | Depuy Acromed, Inc. | KWQ | Class II | 2001-11-27 |
| K012918 | APEX MODULAR ALUMINA FEMORAL HEAD | Apex Surgical, LLC | LZO | Class II | 2001-11-27 |
| K012516 | EBI SPINELINK - II SPINAL FIXATION SYSTEM | Ebi, L.P. | KWP | Class II | 2001-11-27 |
| K012881 | C3 ANTERIOR CERVICAL PLATE SYSTEM | Spine Vision, Inc. | KWQ | Class II | 2001-11-26 |
| K013546 | MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214 | Bionx Implants, Inc. | HWC | Class II | 2001-11-21 |
| K012817 | HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED | Triage Medical, Inc. | HWC | Class II | 2001-11-20 |
| K013540 | EBI XFIX ACCESS PELVIC FIXATOR | Ebi, L.P. | KTT | Class II | 2001-11-20 |
| K012818 | HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX | Triage Medical, Inc. | HWC | Class II | 2001-11-20 |
| K012872 | RESORBABLE SCREW ANCHOR | Arthrotek, Inc. | HWC | Class II | 2001-11-20 |
| K012776 | DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT | Howmedica Osteonics Corp. | JWH | Class II | 2001-11-16 |
| K013440 | ISOBAR SPINAL SYSTEM | Scien'Tx USA, Inc. | MNI | Class II | 2001-11-16 |
| K013557 | LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW | Walter Lorenz Surgical, Inc. | MBI | Class II | 2001-11-16 |
| K012798 | INTEX SCREW | Biomet, Inc. | HWC | Class II | 2001-11-16 |
| K011556 | MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM | Aesculap, Inc. | KWQ | Class II | 2001-11-16 |
| K013441 | ISOLA POLYAXIAL WASHER | Depuyacromed | KWP | Class II | 2001-11-16 |
| K013468 | LONG LENGTH DYAX NAIL | Howmedica Osteonics Corp. | HSB | Class II | 2001-11-16 |
| K013503 | MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR | DePuy Orthopaedics, Inc. | KTT | Class II | 2001-11-16 |
| K013444 | ISOBAR SPINAL SYSTEM | Scien'Tx USA, Inc. | MNH | Class II | 2001-11-16 |
| K013431 | PASS SPINAL SYSTEM | Encore Orthopedics, Inc. | MNI | Class II | 2001-11-15 |
| K012751 | HEALOS BONE GRAFT MATERIAL | Orquest, Inc. | MQV | Class II | 2001-11-14 |
| K012739 | CONVERGE ACETABULAR SYSTEM | Sulzer Orthopedics, Inc. | LPH | Class II | 2001-11-14 |
| K013403 | TRI-FIX SPINAL FIXATION SYSTEM | Endius, Inc. | MNI | Class II | 2001-11-14 |
| K013524 | TROCHANTERIC DYAX NAIL SYSTEM | Howmedica Osteonics Corp. | HSB | Class II | 2001-11-14 |
| K011048 | BSM BONE SUBSTITUTE MATERIAL | DePuy Orthopaedics, Inc. | MQV | Class II | 2001-11-13 |
| K012630 | REPROCESSED LINVATEC ARTHROSCOPIC BURS | Alliance Medical, Inc. | HRX | Class II | 2001-11-09 |
| K012624 | REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS | Medical Instruments Technology, Inc. | HRX | Class II | 2001-11-08 |
| K013378 | EBI XFIX DFS SYSTEM | Ebi, L.P. | KTT | Class II | 2001-11-08 |
| K012652 | REPROCESSED DYONICS ARTHROSCOPIC BURS | Alliance Medical Corp. | HRX | Class II | 2001-11-08 |
| K012655 | CONGRUENT BONE PLATE SYSTEM | Acu Med, Inc. | HRS | Class II | 2001-11-07 |
| K012613 | REPROCSSED LINVATEC SHAVERS | Alliance Medical, Inc. | HRX | Class II | 2001-11-07 |
| K013382 | MODIFICATION TO: STACKABLE CAGE SYSTEM | Depuyacromed | MQP | Class II | 2001-11-07 |
| K012635 | REPROCESSED STRYKER ARTHROSCOPIC SHAVERS | Alliance Medical Corp. | HRX | Class II | 2001-11-07 |
| K010989 | TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL 8119, 8120, 8130, 8131 | Interpore Cross Intl. | MQP | Class II | 2001-11-07 |
| K012611 | REPROCESSED DYONICS ARTHROSCOPIC SHAVERS | Alliance Medical, Inc. | HRX | Class II | 2001-11-07 |
| K012605 | REPROCESSED ATHROSCOPICS BURS | Alliance Medical Corp. | HRX | Class II | 2001-11-07 |
| K013222 | SUMMIT OCCIPITO-CERVICO- THORACIC (OCT) SPINAL SYSTEM | Depuyacromed | MNI | Class II | 2001-11-07 |
| K013350 | MODIFICATION TO DEPUY C-STEM SYSTEM | DePuy Orthopaedics, Inc. | JDI | Class II | 2001-11-07 |
| K012536 | REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES | Sterilmed, Inc. | HRX | Class II | 2001-11-02 |
| K012492 | KADANCE 2000 | Kada Research, Inc. | LBB | Class II | 2001-11-02 |
| K011985 | SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT | Smith & Nephew, Inc. | MAI | Class II | 2001-11-02 |
| K012591 | ADVANCE UNICONDYLAR KNEE SYSTEM | Wrightmedicaltechnologyinc | HRY | Class II | 2001-11-02 |
| K010586 | PALAMED BONE CEMENT | Merck Biomaterial GmbH | LOD | Class II | 2001-10-30 |
| K012465 | MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR | Bonutti Research, Inc. | MAI | Class II | 2001-10-29 |
| K010532 | OSTEOSET BVF KIT | Wrightmedicaltechnologyinc | MQV | Class II | 2001-10-26 |
| K010930 | LIFT VB SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | MQP | Class II | 2001-10-24 |
| K013191 | PASS SPINAL SYSTEM | Encore Orthopedics, Inc. | MNI | Class II | 2001-10-24 |
| K012503 | METAL SCREW ANCHOR | Biomet Manufacturing, Inc. | MBI | Class II | 2001-10-22 |
| K012364 | AML HIP PROSTHESIS | DePuy Orthopaedics, Inc. | LPH | Class II | 2001-10-19 |
| K012961 | SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM | Sulzer Orthopedics, Inc. | JDI | Class II | 2001-10-18 |
| K012346 | VANGUARD REPROCESSED ARTHROSCOPIC BLADES | Vanguard Medical Concepts, Inc. | HRX | Class II | 2001-10-16 |
| K012254 | VBR | Osteotech, Inc. | MQP | Class II | 2001-10-16 |
| K013057 | BIOCUFF,C, MODELS 236018, 236028, 236036 | Bionx Implants, Inc. | MAI | Class II | 2001-10-12 |
| K010869 | EPOCA CUSTOM OFFSET SHOULDER SYSTEM | Argomedical AG | KWT | Class II | 2001-10-11 |
| K012172 | DURACON PS LIPPED TIBIAL INSERT | Howmedica Osteonics | JWH | Class II | 2001-10-10 |
| K013042 | DISCOVERY ELBOW | Biomet Orthopedics, Inc. | JDC | Class II | 2001-10-10 |
| K013295 | TIMX SPINAL SYSTEMS | Depuyacromed | MNH | Class II | 2001-10-09 |
| K013296 | MOSS MIAMI SPINAL SYSTEMS | Depuyacromed | MNH | Class II | 2001-10-09 |
| K013294 | MONARCH SPINAL SYSTEMS | Depuyacromed | MNH | Class II | 2001-10-09 |
| K012971 | ISOLA SPINAL SYSTEMS | Depuyacromed | MNH | Class II | 2001-10-05 |
| K012967 | MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM | Disco-O-Tech Medical Technologies, Ltd. | HSB | Class II | 2001-10-04 |
| K012091 | PRO-FEMUR | Wrightmedicaltechnologyinc | LZO | Class II | 2001-10-03 |
| K012081 | DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM | Medtronic Sofamor Danek, Inc. | JDR | Class II | 2001-10-01 |
| K012173 | DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM | Sulzer Spine-Tech | KWP | Class II | 2001-09-28 |
17,115 clearances in the Orthopedic panel. Data: openFDA.