Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 31
- Latest Decision
- 2008-12-18
Clearances · page 90 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K082527 | ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS | Zimmer, Inc. | HRS | Class II | 2008-12-18 |
| K082715 | DEPUY GLOBAL AP CTA HUMERAL HEAD | DePuy Orthopaedics, Inc. | HSD | Class II | 2008-12-18 |
| K083437 | MODIFICATION TO T2 RECON NAIL SYSTEM | Howmedica Osteonics Corp. | HSB | Class II | 2008-12-18 |
| K081165 | ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM | Spineart | MNH | Class II | 2008-12-17 |
| K082625 | SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES | Synthes (Usa) | HRS | Class II | 2008-12-17 |
| K083392 | NOVATION 12/14 CEMENTED FEMORAL STEMS | Exactech, Inc. | LZO | Class II | 2008-12-17 |
| K082424 | UNITED U2 TOTAL KNEE SYSTEM | United Orthopedic Corp. | JWH | Class II | 2008-12-16 |
| K083070 | TOGGLELOC SYSTEM | Biomet Sports Medicine | MBI | Class II | 2008-12-16 |
| K082509 | EOS SPINAL SYSTEM | Korea Bone Bank Co., Ltd. | MNH | Class II | 2008-12-15 |
| K082705 | BIOPRO BIPOLAR HEAD, MODELS 18130-18152 | Biopro, Inc. | KWY | Class II | 2008-12-15 |
| K082355 | VISIONSENSE STEREOSCOPIC VISION SYSTEM | Visionsense, Ltd. | HRX | Class II | 2008-12-15 |
| K082673 | CONSERVE PRESSFIT FEMORAL COMPONENT | Wrightmedicaltechnologyinc | KXA | Class II | 2008-12-12 |
| K083353 | CAPSURE(R) PS SYSTEM | Spine Wave, Inc. | MNI | Class II | 2008-12-11 |
| K082769 | MESA AND RANGE SPINAL SYSTEMS | K2m, Inc. | KWP | Class II | 2008-12-11 |
| K083364 | 2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424 | DePuy Orthopaedics, Inc. | HRS | Class II | 2008-12-11 |
| K082914 | CLAMPFIX | Synthes Spine | NKB | Class II | 2008-12-11 |
| K082770 | ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL | Zimmer, Inc. | HSB | Class II | 2008-12-11 |
| K083308 | PASS LP SPINAL SYSTEM | Medicrea Technologies | MNI | Class II | 2008-12-10 |
| K082672 | NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT | Novabone Products, LLC | MQV | Class II | 2008-12-09 |
| K082384 | HAV-LOK BUNION CORRECTION SYSTEM | Instratek, Inc. | HTN | Class II | 2008-12-08 |
| K082574 | MAXTORQUE MINI CANNULATED SCREW SYSTEM | Orthohelix Surgical Designs, Inc. | HWC | Class II | 2008-12-08 |
| K072562 | MICROWARE BONE PLATES AND BONE SCREWS | Microware Precision Co., Ltd. | HRS | Class II | 2008-12-04 |
| K082585 | DEPUY ASPHERE M-SPEC HEAD | DePuy Orthopaedics, Inc. | KWA | Class III | 2008-12-04 |
| K071849 | ALLOFUSE GEL AND PUTTY | Allosource, Inc. | MQV | Class II | 2008-12-04 |
| K083230 | MERCURY SPINAL SYSTEM | Spinal Elements, Inc. | NKB | Class II | 2008-12-03 |
| K080241 | DDS STABILIZATION SYSTEM | Paradigm Spine, LLC | NQP | Class II | 2008-11-28 |
| K082172 | MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM | Mako Surgical Corporation | HSX | Class II | 2008-11-28 |
| K080398 | SI JOINT FUSION SYSTEM | SI-BONE, Inc. | OUR | Class II | 2008-11-26 |
| K080649 | POGO SCREW | Fxdevices | HWC | Class II | 2008-11-25 |
| K082949 | ORTHOPEDIATRICS BONE SCREWS | OrthoPediatrics Corp. | HWC | Class II | 2008-11-25 |
| K082844 | BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE | Encore Medical L.P. | LZO | Class II | 2008-11-25 |
| K082358 | SMITH & NEPHEW, INC. PATIENT MATCHED TECHNOLOGY | Smith & Nephew, Inc. | JWH | Class II | 2008-11-25 |
| K082575 | ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES | Apatech , Ltd. | MQV | Class II | 2008-11-25 |
| K082002 | PROGENIX PLUS | Medtronic Sofamor Danek | MQV | Class II | 2008-11-24 |
| K082572 | USS ILIOSACRAL, USS POLYAXIAL | Synthes Spine | NKB | Class II | 2008-11-24 |
| K082807 | SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYSTEM WITH EXPANDED INDICATIONS | Synthes (Usa) | HRS | Class II | 2008-11-24 |
| K081025 | ISOELASTICU | Remi Sciences, Inc. | KXE | Class II | 2008-11-21 |
| K081080 | TSRH SPINAL SYSTEM | Medtronic Sofamor Danek | NKB | Class II | 2008-11-21 |
| K082991 | BIOLOX DELTA CERAMIC FEMORAL HEAD | Aesculap Implant Systems, Inc. | LZO | Class II | 2008-11-20 |
| K081380 | THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS | K2m, Inc. | KWQ | Class II | 2008-11-19 |
| K082650 | SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL | Synthes (Usa) | KTT | Class II | 2008-11-18 |
| K082500 | DEPUY SIGMA CR-F FEMORAL COMPONENT | DePuy Orthopaedics, Inc. | JWH | Class II | 2008-11-18 |
| K083071 | VERTEX RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek | KWP | Class II | 2008-11-14 |
| K081906 | PROTEX CT CERVICOTHORACIC SPINAL SYSTEM | Globus Medical, Inc. | KWP | Class II | 2008-11-14 |
| K082381 | GENEX | Biocomposites, Ltd. | MQV | Class II | 2008-11-14 |
| K081673 | DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE | Ionics Medical Corp. | MAX | Class II | 2008-11-14 |
| K082128 | DEPUY SPINE LATERAL CAGE SYSTEM | Depuy Spine | MAX | Class II | 2008-11-14 |
| K083028 | MODIFICATION TO: NUVASIVE SPHERX II SYSTEM | Nuvasive, Inc. | NKB | Class II | 2008-11-13 |
| K082187 | BIOMET ANTERIOR LUMBAR PLATE | Ebi, L.P. | KWQ | Class II | 2008-11-13 |
| K082624 | SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES | Synthes (Usa) | HRS | Class II | 2008-11-10 |
| K082310 | HOLLYWOOD, PACIFICA, REDONDO, VENTURA | Seaspine, Inc. | MAX | Class II | 2008-11-10 |
| K082072 | SYNTHES (USA) 3.5MM LCP HOOK PLATE | Synthes (Usa) | HRS | Class II | 2008-11-07 |
| K082282 | HEALIX TI ANCHOR | Depuy Mitek, A Johnson & Johnson Co. | HWC | Class II | 2008-11-07 |
| K081011 | AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45 | Arex USA | HWC | Class II | 2008-11-07 |
| K083033 | VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE | Orthovita, Inc. | MQV | Class II | 2008-11-06 |
| K081979 | ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE | Apatech , Ltd. | MQV | Class II | 2008-11-06 |
| K082320 | DARCO SMALL SCREW | Wrightmedicaltechnologyinc | HWC | Class II | 2008-11-05 |
| K082252 | INDEPENDENCE SPACER | Globus Medical, Inc. | OVD | Class II | 2008-11-05 |
| K081145 | MODIFICATION TO 4CIS VANE SPINE SYSTEM | Solco Biomedical Co., Ltd. | MNI | Class II | 2008-11-05 |
| K082215 | OSTEORAPTOR SUTURE ANCHOR | Smith & Nephew Inc., Endoscopy Division | JDR | Class II | 2008-11-03 |
| K082078 | ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM: DISTAL HUMERAL AND PROXIMAL ULNA PLATES | Zimmer, Inc. | HRS | Class II | 2008-11-03 |
| K082942 | MODFICATION TO: EXPEDIUM SPINE SYSTEM | Depuy Spine, Inc. | NKB | Class II | 2008-10-31 |
| K080979 | STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT | Biomet Manufacturing Corp | KWY | Class II | 2008-10-31 |
| K082821 | SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM | Spine Smith Partners L.P. | KWQ | Class II | 2008-10-31 |
| K082906 | UNITY BETA ANCHOR SYSTEM | Bonutti Research, Inc. | HWC | Class II | 2008-10-30 |
| K082826 | VANGUARD CR STEM HOUSINGS | Biomet Manufacturing Corp | JWH | Class II | 2008-10-24 |
| K082839 | DISTAL RADIO-ULNAR JOINT IMPLANT | Aptis Medical, LLC | KXE | Class II | 2008-10-24 |
| K082120 | AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS | Tornier | KWS | Class II | 2008-10-24 |
| K081023 | EVOLIS TOTAL KNEE SYSTEM | Medacta International S.A. | JWH | Class II | 2008-10-22 |
| K082088 | MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II | Mako Surgical Corp. | KRR | Class II | 2008-10-22 |
| K082095 | ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE | Smith & Nephew Endoscopy, Inc. | HTN | Class II | 2008-10-21 |
| K082774 | LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE | Lanx, LLC | MAX | Class II | 2008-10-21 |
| K082260 | INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES | Calvary Spine, LLC | MAX | Class II | 2008-10-17 |
| K081348 | TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD | TriMed, Inc. | MBI | Class II | 2008-10-17 |
| K082797 | BLACKSTONE PEDICLE SCREW SYSTEM | Blackstone Medical, Inc. | NKB | Class II | 2008-10-17 |
| K082375 | ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM | OrthoPediatrics Corp. | HTY | Class II | 2008-10-17 |
| K081127 | ACCIN TOTAL KNEE SYSTEM | Accelerated Innovation, LLC | JWH | Class II | 2008-10-17 |
| K081759 | NCB POLYAXIAL LOCKING PLATE SYSTEM, PROXIMAL HUMERAL PLATES, ZIMMER UNIVERSAL LOCKING SYSTEM, 3.5MM TIVANIUM TI-6AL-4V | Zimmer GmbH | HRS | Class II | 2008-10-16 |
| K081196 | SPINAL USA VBR SYSTEM | Spinal USA | MAX | Class II | 2008-10-16 |
| K082615 | GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES | Osteotech, Inc. | MQV | Class II | 2008-10-16 |
| K082732 | MODIFICATION TO: CAPSTONE SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | MAX | Class II | 2008-10-16 |
| K082338 | POLYBONE GRANULE & BLOCK | Kyung Won Medical Co., Ltd. | MQV | Class II | 2008-10-16 |
| K082081 | MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III | Mako Surgical Corp. | HSX | Class II | 2008-10-15 |
| K082446 | BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS | Biomet, Inc. | KWA | Class III | 2008-10-15 |
| K082398 | ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS | Encore Medical L.P. | LZO | Class II | 2008-10-15 |
| K082332 | NUVASIVE SPHERX SYSTEM | Nuvasive, Inc. | NKB | Class II | 2008-10-10 |
| K082018 | T2 FLEXIBLE NAIL | Howmedica Osteonics Corp. | HSB | Class II | 2008-10-10 |
| K081107 | CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS | K2m, Inc. | KWP | Class II | 2008-10-10 |
| K082017 | STARR FRAME STEINMANN PIN | Starr Frame, LLC | HTY | Class II | 2008-10-10 |
| K082236 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek | NKB | Class II | 2008-10-10 |
| K081832 | ENSPLINTCMX CLAVICLE PIN | Sonoma Orthopedic Products, Inc. | HSB | Class II | 2008-10-10 |
| K081717 | TRICOS A RESORBABLE BONE SUBSTITUTE | Baxter Healthcare Corp | MQV | Class II | 2008-10-10 |
| K080399 | DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE | Musculoskeletal Transplant Foundation | MBP | Class II | 2008-10-10 |
| K082702 | EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY | Exactech, Inc. | PHX | Class II | 2008-10-10 |
| K082592 | LDR SPINE EASYSPINE SYSTEM | Ldr Spine USA | NKB | Class II | 2008-10-08 |
| K082608 | RADIUS SPINAL SYSTEM, VITALLIUM ROD #486613601 | Stryker Spine | NKB | Class II | 2008-10-07 |
| K082442 | MODIFICATION TO MICROFUSE BONE VOID FILLER | Globus Medical, Inc. | MQV | Class II | 2008-10-07 |
| K081952 | SYNERGY SPINAL SYSTEM (6.35 POLARIS) | Biomet Spine | NKB | Class II | 2008-10-07 |
| K082032 | SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310) | Abbott Spine, Inc. | NKB | Class II | 2008-10-06 |
| K082069 | PASS 2 SPINAL SYSTEM | Medicrea Technologies | MNI | Class II | 2008-10-03 |
17,115 clearances in the Orthopedic panel. Data: openFDA.