Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 38
- Latest Decision
- 2008-10-03
Clearances · page 91 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K082577 | PASS LP SPINAL SYSTEM | Medicrea Technologies | MNH | Class II | 2008-10-03 |
| K082567 | STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION | Howmedica Osteonics Corp. | HRY | Class II | 2008-10-03 |
| K081880 | ATLAS SPINE SPACER | Atlas Spine, Inc. | ODP | Class II | 2008-10-02 |
| K081611 | NUVASIVE COROENT SYSTEM | Nuvasive, Inc. | ODP | Class II | 2008-10-02 |
| K081893 | OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500 | Arthrocare Corp. | HWC | Class II | 2008-10-01 |
| K081448 | ENCORE SHOULDER REVISION GLENOID | Encore Medical L.P. | MBF | Class II | 2008-09-30 |
| K082469 | UNITED U2 PATELLA | United Orthopedic Corp. | JWH | Class II | 2008-09-26 |
| K081860 | ZIMMER SEGMENTAL SYSTEM VARIABLE STIFFNESS STEM EXTENSIONS AND INTERCALARY SEGMENTS | Zimmer, Inc. | LZO | Class II | 2008-09-26 |
| K082037 | SEEPLATE CERVICAL PLATE SYSTEM | Amedica Corp. | KWQ | Class II | 2008-09-26 |
| K082070 | NUVASIVE LATERAL PLATE SYSTEM | Nuvasive, Inc. | KWQ | Class II | 2008-09-24 |
| K081883 | MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM | Us Spine | MNH | Class II | 2008-09-24 |
| K081817 | ACCELL TBM-R | Isotis Orthobiologics, Inc. | MBP | Class II | 2008-09-24 |
| K082453 | 4CIS SOLAR AND APOLLON SPINE SYSTEMS | Solco Biomedical Co., Ltd. | MNH | Class II | 2008-09-23 |
| K081293 | UNIVATION UNICONDYLAR KNEE SYSTEM | Aesculap Implant Systems, Inc. | HRY | Class II | 2008-09-22 |
| K081730 | NOVEL CERVICAL SPINAL SPACER SYSTEM | Alphatec Spine, Inc. | ODP | Class II | 2008-09-19 |
| K082516 | PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS | Smith & Nephew, Inc. | HWC | Class II | 2008-09-17 |
| K082270 | OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM | Vertiflex, Inc. | MAX | Class II | 2008-09-16 |
| K081684 | BLACKSTONE PEDICLE SCREW SYSTEM | Blackstone Medical, Inc. | NKB | Class II | 2008-09-15 |
| K082342 | MODIFICATION TO CAPSTONE SPINAL SYSTEM | Medtronic Sofamor Danek | MAX | Class II | 2008-09-12 |
| K082073 | ACTIFUSE FLOW BONE GRAFT SUBSTITUTE | Apatech , Ltd. | MQV | Class II | 2008-09-11 |
| K081711 | LUCENT MAGNUM+ | Spinal Elements, Inc. | OVD | Class II | 2008-09-11 |
| K082273 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM | Depuy Spine, Inc. | KWQ | Class II | 2008-09-10 |
| K081898 | EXPEDIUM SPINE SYSTEM | Depuy Spine, Inc. | NKB | Class II | 2008-09-10 |
| K081374 | CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE | Wrightmedicaltechnologyinc | HRS | Class II | 2008-09-09 |
| K082146 | METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD | Aesculap Implant Systems, Inc. | LWJ | Class II | 2008-09-09 |
| K082293 | SURGVIEW INTEGRATED VISUALIZATION SYSTEM | Biovision Technologies, LLC | HRX | Class II | 2008-09-09 |
| K081623 | SYNTHES RIB FIXATION SYSTEM | Synthes (Usa) | HRS | Class II | 2008-09-08 |
| K081016 | SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM | Smith & Nephew, Inc. | PHX | Class II | 2008-09-05 |
| K081614 | ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR CAGES | Interbody Innovations, Llp | ODP | Class II | 2008-09-05 |
| K080992 | AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM | Aesculap Implant Systems, Inc. | HRS | Class II | 2008-09-04 |
| K082235 | BLACKSTONE PILLAR XL PEEK SPACERS | Blackstone Medical, Inc. | MAX | Class II | 2008-09-04 |
| K081758 | HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015 | Depuy Spine, Inc. | MQV | Class II | 2008-09-03 |
| K082195 | MODIFICATIONS TO EXPEDIUM SPINE SYSTEM | Depuy Spine, Inc. | NKB | Class II | 2008-09-03 |
| K081588 | RE-ZORB PLATING SYSTEM | Acute Innovations, LLC | HRS | Class II | 2008-09-03 |
| K082022 | OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++ | Exactech, Inc. | JWH | Class II | 2008-09-02 |
| K081568 | ANTEGRA-T | Synthes Spine Co.Lp | KWQ | Class II | 2008-09-02 |
| K081622 | UNIVERSAL CLAMP STAINLESS STEEL SYSTEM | Abbott Spine, Inc. | JDQ | Class II | 2008-08-29 |
| K081934 | EXTREMITY MEDICAL COMPRESSION SCREW | Extremity Medical, LLC | HWC | Class II | 2008-08-29 |
| K082239 | DEPUY C-STEM AMT | DePuy Orthopaedics, Inc. | JDI | Class II | 2008-08-29 |
| K081849 | BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE | Blackstone Medical, Inc. | OVD | Class II | 2008-08-28 |
| K080873 | OPACITY + BONE CEMENT | Teknimed, S.A. | NDN | Class II | 2008-08-28 |
| K080405 | SYGNAL DBM | Musculoskeletal Transplant Foundation | MBP | Class II | 2008-08-28 |
| K082194 | LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002 | Laurimed, LLC | HRX | Class II | 2008-08-28 |
| K082112 | T2 XVBR SPINAL SYSTEM | Medtronic Sofamor Danek | MQP | Class II | 2008-08-27 |
| K081511 | 2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S | Smith & Nephew, Inc. | MBI | Class II | 2008-08-26 |
| K081546 | SMALL BONE LOCKING PLATING SYSTEM | DePuy Orthopaedics, Inc. | HRS | Class II | 2008-08-26 |
| K081558 | PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC | Pioneer Surgical Technology | MQV | Class II | 2008-08-25 |
| K081566 | SMITH & NEPHEW OXINIUM DH FEMORAL HEADS | Smith & Nephew, Inc. | LPH | Class II | 2008-08-21 |
| K080259 | JMEA CANNULATED BONE SCREW SYSTEM | Jmea Corporation | HWC | Class II | 2008-08-20 |
| K081679 | REVELATION HIP STEM, MODELS, 427-01, 427-02; LINEAR HIP STEM, MODELS 425-00, 425-05 | Encore Medical L.P. | LPH | Class II | 2008-08-20 |
| K081586 | REPROCESSED EXTERNAL FIXATION DEVICE | Sterilmed, Inc. | KTT | Class II | 2008-08-18 |
| K081038 | ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM | Medtronic Sofamor Danek | KWQ | Class II | 2008-08-15 |
| K080685 | HIPLOC COMPRESSION HIP SCREW | Biomet Manufacturing, Inc. | JDO | Class II | 2008-08-15 |
| K073432 | TRAUSON BONE PLATE | Trauson (Jiangsu) Medical Instrument Co., Ltd. | HRS | Class II | 2008-08-13 |
| K081342 | REPROCESSED EXTERNAL FIXATION ACCESSORIES | Sterilmed, Inc. | KTT | Class II | 2008-08-13 |
| K081390 | BIOACTIF OSTEOTRANS INTERFENCE SCREW | Takiron Co., Ltd. | HWC | Class II | 2008-08-12 |
| K082148 | SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSION | Synthes (Usa) | HSB | Class II | 2008-08-11 |
| K080990 | DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER | DePuy Orthopaedics, Inc. | HSD | Class II | 2008-08-08 |
| K081636 | PEEK-OPTIMA ALIF SPACER | Biomet Spine | MAX | Class II | 2008-08-07 |
| K073499 | VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES | Zimmer, Inc. | JDL | Class III | 2008-08-07 |
| K081973 | METHA SHORT STEM HIP SYSTEM; MODULAR HIP SYSTEM; EXCIA HIP SYSTEM | Aesculap Implant Systems, Inc. | LZO | Class II | 2008-08-07 |
| K081051 | SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE | Spine View, Inc. | HRX | Class II | 2008-08-07 |
| K081149 | BIOPRO GO-EZ SCREW | Biopro, Inc. | HWC | Class II | 2008-08-05 |
| K081968 | MODIFICATION TO LUCENT | Spinal Elements, Inc. | MAX | Class II | 2008-08-05 |
| K081510 | TIGER CANNULATED SCREW SYSTEM | Trilliant Surgical, Ltd. | HWC | Class II | 2008-08-04 |
| K081876 | OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING | Osteomed LP | KWD | Class II | 2008-08-01 |
| K081124 | MDF REVISION HIP SYSTEM | Smith & Nephew, Inc. | MEH | Class II | 2008-07-31 |
| K081244 | LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS | Biomet Trauma | KTT | Class II | 2008-07-30 |
| K080426 | MAESTRO WRIST FRACTURE IMPLANT | Biomet Manufacturing Corp | JWJ | Class II | 2008-07-29 |
| K081497 | OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503) | Arthrocare Corp. | MBI | Class II | 2008-07-28 |
| K082014 | STRYKER SPINE AVS PL PEEK SPACERS | Stryker Corp. | MAX | Class II | 2008-07-28 |
| K080664 | RELIEVE LAMINOPLASTY FIXATION SYSTEM | Globus Medical, Inc. | NQW | Class II | 2008-07-25 |
| K081790 | MODIFICATION TO SINGLE PLANAR MULTI AXIS (SPMA) PEDICLE SCREW SYSTEM | Trinity Orthopedics, LLC | MNI | Class II | 2008-07-24 |
| K081351 | MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT | Smith & Nephew, Inc. | HSX | Class II | 2008-07-24 |
| K081331 | FIXXSURE CROSS LINK | Spineworks, LLC | MNH | Class II | 2008-07-23 |
| K081177 | BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM | Blackstone Medical, Inc. | MAX | Class II | 2008-07-23 |
| K081353 | SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES | Synthes (Usa) | HRS | Class II | 2008-07-23 |
| K073159 | TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5 | Trauson (Jiangsu) Medical Instrument Co., Ltd. | HWC | Class II | 2008-07-23 |
| K081111 | LEGION HINGE KNEE SYSTEM | Smith & Nephew, Inc. | KRO | Class II | 2008-07-23 |
| K080841 | COSMIC SYSTEM | Ulrich GmbH & Co. KG | MNI | Class II | 2008-07-23 |
| K081171 | TRITANIUM ACETABULAR SHELL SYSTEM | Howmedica Osteonics Corp. | LPH | Class II | 2008-07-22 |
| K081407 | ORTHOPEDIATRICS PEDIPLATES SYSTEM | OrthoPediatrics Corp. | HRS | Class II | 2008-07-22 |
| K081227 | PLEXUR M | Osteotech, Inc. | MQV | Class II | 2008-07-22 |
| K081452 | SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM | Synthes (Usa) | HSB | Class II | 2008-07-18 |
| K081631 | SINTEA BIOTECH PLS MULTI-AXIAL SCREWS | Sintea Biotech, Inc. | MNH | Class II | 2008-07-18 |
| K081513 | MERETE 3.0 AND 3.5 MM LOCKING SCREWS | Merete Medical GmbH | HWC | Class II | 2008-07-18 |
| K081284 | VARIAX DISTAL FIBULA PLATE | Howmedica Osteonics Corp. | KTT | Class II | 2008-07-18 |
| K081059 | AEQUALIS REVERSED SHOULDER PROSTHESIS | Tornier | PHX | Class II | 2008-07-17 |
| K081172 | COMPOSITE HITCH SUTURE ANCHOR | Biomet Manufacturing Corp | JDR | Class II | 2008-07-17 |
| K081700 | SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION | Synthes (Usa) | HWC | Class II | 2008-07-17 |
| K081707 | AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS | Tornier, Inc. | KWS | Class II | 2008-07-17 |
| K081098 | ENDOBUTTON CONTINUOUS LOOP (CL) | Smith & Nephew Inc., Endoscopy Division | JDR | Class II | 2008-07-16 |
| K073115 | ORTHOMESH | Synthes (Usa) | HRS | Class II | 2008-07-15 |
| K081108 | MONOPOLY PEDICLE SCREW SYSTEM | Signus Medical, LLC | NKB | Class II | 2008-07-14 |
| K081418 | SPINAL ELEMENTS BUTTRESS PLATE SYSTEM | Spinal Elements, Inc. | KWQ | Class II | 2008-07-14 |
| K081132 | SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM | Spine Smith Partners L.P. | KWQ | Class II | 2008-07-14 |
| K072291 | CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR | Conmed Linvatec | HWC | Class II | 2008-07-14 |
| K071810 | INION SPINAL GRAFT CONTAINMENT SYSTEM | Inion , Ltd. | OJB | Class II | 2008-07-11 |
| K080122 | SOPRO 670 ARTHROSCOPIC PUMP | Sopro | HRX | Class II | 2008-07-11 |
| K080778 | ENSPLINT TM BONE SCREW | Sonoma Orthopedic Products, Inc. | HWC | Class II | 2008-07-10 |
17,115 clearances in the Orthopedic panel. Data: openFDA.