Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 37
- Latest Decision
- 2008-02-19
Clearances · page 94 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K073331 | DVO EXTENDED ARTICULATION HUMERAL HEADS | Dvo Extremity Solutions, LLC | HSD | Class II | 2008-02-19 |
| K073245 | EXTENDED VERTIFLEX SPINAL SCREW SYSTEM | Vertiflex, Inc. | NKB | Class II | 2008-02-15 |
| K073076 | HOFFMANN LIGHT SYSTEM | Howmedica Osteonics Corp. | KTT | Class II | 2008-02-15 |
| K073527 | VARIAX ELBOW SYSTEM | Howmedica Osteonics Corp. | KTT | Class II | 2008-02-14 |
| K073602 | MODIFICATION TO: APEX KNEE SYSTEM | Omnlife Science | JWH | Class II | 2008-02-14 |
| K073420 | BLACKSTONE ASCENT MULTIAXIAL SCREWS | Blackstone Medical, Inc. | KWP | Class II | 2008-02-14 |
| K080143 | MODIFICATION TO STRYKER SPINE OASYS SYSTEM | Stryker Spine | MNI | Class II | 2008-02-14 |
| K073154 | FACTS HAND AND PINCH GRIP COMBO | Global Services Group, LLC | LBB | Class II | 2008-02-14 |
| K073669 | ORIA NATURA SPACER | Choicespine, LP | MAX | Class II | 2008-02-13 |
| K080111 | ARTHREX COMPRESSION STAPLE | Arthrex, Inc. | JDR | Class II | 2008-02-13 |
| K073437 | THOR ANTERIOR PLATING SYSTEM | Stryker Spine | KWQ | Class II | 2008-02-13 |
| K073337 | MECTACER BIOLOX FORTE-FEMORAL HEADS | Medacta International S.A. | LZO | Class II | 2008-02-13 |
| K073349 | RELIANCE BUTTRESS WASHER SYSTEM | Reliance Medical Systems, LLC | KWQ | Class II | 2008-02-13 |
| K072981 | SYNTHES ZERO-P | Synthes Spine Co.Lp | OVE | Class II | 2008-02-11 |
| K073510 | ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM | Endius, Inc. | NKB | Class II | 2008-02-11 |
| K073347 | DYNESYS TOP-LOADING SPINAL SYSTEM | Zimmer Spine, Inc. | NQP | Class II | 2008-02-08 |
| K073320 | CIMPLICITY SPINAL SYSTEM | Spine Smith Partners L.P. | ODP | Class II | 2008-02-07 |
| K080071 | SIDEKICK RAIL FIXATOR | Wrightmedicaltechnologyinc | KTT | Class II | 2008-02-07 |
| K070761 | SANATMETAL NAILS AND PINS | Sanatmetal Mfr. of Orthopaedic/Traumatologic Prod. | HSB | Class II | 2008-02-07 |
| K072656 | DYNASTY CERAMIC FEMORAL HEAD | Wrightmedicaltechnologyinc | LZO | Class II | 2008-02-06 |
| K072857 | TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT | Medacta International S.A. | JDI | Class II | 2008-02-04 |
| K073531 | ACCIN PEDICLE SCREW SYSTEM | Accelerated Innovation, LLC | MNH | Class II | 2008-02-04 |
| K071199 | BONALIVE GRANULES | Vivoxid , Ltd. | MQV | Class II | 2008-02-01 |
| K073530 | ACCIN ANTERIOR CERVICAL PLATE SYSTEM | Accelerated Innovation, LLC | KWQ | Class II | 2008-01-31 |
| K073202 | ARDIS SPACER | Abbott Spine, Inc. | MAX | Class II | 2008-01-30 |
| K073267 | ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM | Endius, Inc. | NKB | Class II | 2008-01-30 |
| K073413 | DEPUY ASR 300 ACETABULAR CUP SYSTEM | DePuy Orthopaedics, Inc. | KWA | Class III | 2008-01-30 |
| K073135 | SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS | Synthes (Usa) | LXT | Class II | 2008-01-29 |
| K073430 | VALEO PEDICLE SCREW SPINAL SYSTEM | Amedica Corp. | NKB | Class II | 2008-01-29 |
| K073676 | DEPUY DELTA XTEND REVERSE SHOULDER HIGH MOBILITY CUP | DePuy Orthopaedics, Inc. | PHX | Class II | 2008-01-29 |
| K073275 | NUVASIVE HELIX MINI ACP SYSTEM | Nuvasive, Inc. | KWQ | Class II | 2008-01-29 |
| K080026 | QUANTUM-MIS CANNULATED SYSTEM | Pioneer Surgical Technology | MNI | Class II | 2008-01-28 |
| K080075 | MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM | Elite Surgical Supplies (Pty), Ltd. | MNI | Class II | 2008-01-28 |
| K072943 | BUTREX BUTTRESS PLATING SYSTEM | X-Spine Systems, Inc. | KWQ | Class II | 2008-01-28 |
| K073233 | ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS | Advanced Bio-Surfaces, Inc. | HSH | Class II | 2008-01-28 |
| K072238 | BIOSET XCH | Regeneration Technologies, Inc. | MQV | Class II | 2008-01-25 |
| K073649 | BENGAL STACKABLE CAGE SYSTEM | Depuy Spine, Inc. | MQP | Class II | 2008-01-25 |
| K072415 | STALIF (TM) C | Surgicraft , Ltd. | OVE | Class II | 2008-01-25 |
| K073654 | BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR | Blackstone Medical, Inc. | KWP | Class II | 2008-01-24 |
| K073529 | DEPUY SIGMA PS FEMORAL COMPONENTS | DePuy Orthopaedics, Inc. | JWH | Class II | 2008-01-24 |
| K073144 | LANX INTERVERTEBRAL BODY FUSION DEVICE | Lanx, LLC | MAX | Class II | 2008-01-24 |
| K072969 | DSS | Paradigm Spine, LLC | NQP | Class II | 2008-01-24 |
| K073351 | CRYSTAL | Spinal Elements, Inc. | ODP | Class II | 2008-01-24 |
| K080024 | ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01 | K2m, Inc. | MQP | Class II | 2008-01-24 |
| K072991 | PATRIOT SPACERS: COLONIAL ACDF | Globus Medical, Inc. | ODP | Class II | 2008-01-18 |
| K072970 | PATRIOT SPACERS | Globus Medical, Inc. | MAX | Class II | 2008-01-18 |
| K071456 | ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT | Arthrex, Inc. | MAI | Class II | 2008-01-17 |
| K073412 | GRYPHON BR AND HEALIX BR ANCHORS | Depuy Mitek, A Johnson & Johnson Company | MAI | Class II | 2008-01-17 |
| K072879 | INNERVUE DIAGNOSTIC SCOPE SYSTEM | Biomet Orthopedics, Inc. | HRX | Class II | 2008-01-14 |
| K073514 | TRANS1 AXIAL FIXATON SYSTEM | Trans1 Incorporated | KWQ | Class II | 2008-01-11 |
| K072434 | SYNTHES OC FUSION AND SYNAPSE SYSTEMS | Synthes Spine Co.Lp | MNI | Class II | 2008-01-10 |
| K072417 | SMITH & NEPHEW MIS HIP STEM | Smith & Nephew, Inc. | LPH | Class II | 2008-01-10 |
| K072703 | PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM | Pioneer Surgical Technology | KWQ | Class II | 2008-01-10 |
| K073068 | ACCIN HIP SYSTEM | Accelerated Innovation, LLC | LPH | Class II | 2008-01-10 |
| K072888 | REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED, HEMISPHERICAL AND FLARED) | Encore Medical L.P. | LPH | Class II | 2008-01-10 |
| K073505 | MODIFICATION TO VALEO VBR | Amedica Corp. | MQP | Class II | 2008-01-09 |
| K072265 | PROGENIX DMB PUTTY | Medtronic Sofamor Danek | MQV | Class II | 2008-01-09 |
| K072432 | F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE | Hand Biomechanics Lab, Inc. | JEC | Class II | 2008-01-09 |
| K073479 | KINETIC-SL ANTERIOR CERVICAL PLATE SYSTEM | Life Spine | KWQ | Class II | 2008-01-09 |
| K072963 | DEPUY PINNACLE ALTRX ACETABULAR LINERS | DePuy Orthopaedics, Inc. | LPH | Class II | 2008-01-09 |
| K072367 | REPIPHYSIS LIMB SALVAGE PROXIMAL FEMUR AND TOTAL FEMUR | Wrightmedicaltechnologyinc | KRO | Class II | 2008-01-09 |
| K073481 | THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES | Conmed Linvatec | MBI | Class II | 2008-01-07 |
| K073535 | BIOFOAM BONE WEDGE | Wrightmedicaltechnologyinc | HRS | Class II | 2008-01-07 |
| K072575 | TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE | Stryker Orthopaedics | MBH | Class II | 2008-01-07 |
| K072121 | TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER | Zimmer, Inc. | KWZ | Class II | 2008-01-07 |
| K073480 | LIFE SPINE CROSS CONNECTOR | Life Spine | NKB | Class II | 2008-01-04 |
| K072914 | NATURAL BRIDGE LP TRANSVERSE CONNECTORS | K2m, Inc. | MNI | Class II | 2008-01-03 |
| K073517 | H-LINK INTEGRATED ROD | Globus Medical, Inc. | NKB | Class II | 2008-01-03 |
| K071905 | POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) | Lanx, LLC | KWQ | Class II | 2007-12-28 |
| K072791 | ORACLE SPACER, OPAL SPACER | Synthes Spine | MAX | Class II | 2007-12-26 |
| K072231 | THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE) | Esm Technologies, LLC | KWQ | Class II | 2007-12-26 |
| K073348 | LUCENT MAGNUM | Spinal Elements, Inc. | MAX | Class II | 2007-12-26 |
| K071375 | MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE) | Disc-O-Tech Medical Technologies, Ltd. | NDN | Class II | 2007-12-21 |
| K072407 | BODYFORM THORACIC FIXATION SYSTEM | Theken Spine, LLC | KWQ | Class II | 2007-12-21 |
| K072605 | MALIBU SPINAL SYSTEM | Seaspine, Inc. | NKB | Class II | 2007-12-20 |
| K073325 | LEGION POROUS PRIMARY | Smith & Nephew, Inc. | MBH | Class II | 2007-12-20 |
| K073175 | JOURNEY UNICONDYLAR FEMORAL IMPLANT | Smith & Nephew, Inc. | HSX | Class II | 2007-12-20 |
| K071187 | MICROFUSE BONE VOID FILLER | Globus Medical, Inc. | MQV | Class II | 2007-12-20 |
| K063686 | DEPUY LPS DISTAL FEMORAL COMPONENT | DePuy Orthopaedics, Inc. | JWH | Class II | 2007-12-20 |
| K071616 | ARC SURGICAL BIOTRAK PIN SYSTEM | Arc Surgical, LLC | HTY | Class II | 2007-12-19 |
| K072961 | LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) | Sra Developments, Ltd. | JDX | Class II | 2007-12-19 |
| K072537 | CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM | Creaspine Sas | MQP | Class II | 2007-12-18 |
| K071679 | METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS | Disc-O-Tech Medical Technologies, Ltd. | HSB | Class II | 2007-12-17 |
| K073186 | SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM | Synthes (Usa) | HRS | Class II | 2007-12-17 |
| K071876 | CROSS.BONE | TriMed, Inc. | MQV | Class II | 2007-12-17 |
| K072832 | ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM | DePuy Orthopaedics, Inc. | HRS | Class II | 2007-12-14 |
| K072154 | FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM | Encore Medical L.P. | LPH | Class II | 2007-12-14 |
| K073172 | BEACON STABILIZATION SYSTEM | Globus Medical, Inc. | NKB | Class II | 2007-12-13 |
| K072866 | ISSYS LP SPINAL FIXATION SYSTEM | Custom Spine, Inc. | KWP | Class II | 2007-12-13 |
| K073248 | MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEM | Mako Surgical Corp. | HSX | Class II | 2007-12-12 |
| K072804 | COMPREHENSIVE RS SHOULDER SYSTEM | Biomet Manufacturing Corp | PHX | Class II | 2007-12-12 |
| K071942 | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek | KWP | Class II | 2007-12-11 |
| K072785 | TWINFIX FT PK | Smith & Nephew Inc., Endoscopy Division | HWC | Class II | 2007-12-10 |
| K072226 | IMPIX SPACER | Medicrea Technologies | MAX | Class II | 2007-12-10 |
| K073226 | CINCH KNOTLESS FIXATION IMPLANT SYSTEM | C2m Medical, Inc. | MBI | Class II | 2007-12-07 |
| K070021 | ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0 | Jg Medical Products, LLC | HRX | Class II | 2007-12-07 |
| K072840 | ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM | Endius, Inc. | NKB | Class II | 2007-12-07 |
| K072118 | STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT | Stryker Corp. | NDN | Class II | 2007-12-07 |
| K073126 | EXPEDIUM SPINE SYSTEM | Depuy Spine, Inc. | NKB | Class II | 2007-12-06 |
| K072531 | LEGION STEM WITH HOLES | Smith & Nephew, Inc. | JWH | Class II | 2007-12-06 |
17,115 clearances in the Orthopedic panel. Data: openFDA.