Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 35
- Latest Decision
- 2007-12-06
Clearances · page 95 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K073151 | MANTIS SPINAL SYSTEM | Stryker Corp. | NKB | Class II | 2007-12-06 |
| K073125 | VALEO VBR | Amedica Corp. | MQP | Class II | 2007-12-05 |
| K071941 | MEMOMETAL BONE ANCHORS | Memometal Technologies | HWC | Class II | 2007-12-04 |
| K071795 | NUVASIVE COROENT SYSTEM | Nuvasive, Inc. | MAX | Class II | 2007-12-04 |
| K070015 | COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT | Biomet Manufacturing Corp | LOD | Class II | 2007-11-30 |
| K071667 | SYNTHES VECTRA-ONE SYSTEM | Synthes Spine | KWQ | Class II | 2007-11-30 |
| K072672 | SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIES | Abbott Spine, Inc. | NKB | Class II | 2007-11-28 |
| K072578 | SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM | Synthes (Usa) | HSD | Class II | 2007-11-28 |
| K072922 | 3S HEMI TOE | Trilliant Surgical, Ltd. | KWD | Class II | 2007-11-28 |
| K072650 | IST ANTERIOR CERVICAL PLATE SYSTEM | Innovative Spinal Technologies, Inc. | KWQ | Class II | 2007-11-28 |
| K073102 | BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS | Biomet Manufacturing Corp | LZO | Class II | 2007-11-27 |
| K073054 | MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER | Cayenne Medical, Inc. | HWC | Class II | 2007-11-27 |
| K072619 | NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTS | Zimmer, Inc. | MBH | Class II | 2007-11-21 |
| K071927 | MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT | Depuy Spine, A Johnson & Johnson Company | NDN | Class II | 2007-11-21 |
| K072133 | AVAFLEX VERTEBRAL AUGMENTATION NEEDLE | Cardinal Health, Inc. | NDN | Class II | 2007-11-20 |
| K072858 | TC-PLUS PRIMARY KNEE SYSTEM | Smith & Nephew, Inc. | JWH | Class II | 2007-11-20 |
| K072022 | VALEO PEDICLE SCREW SPINAL SYSTEM | Amedica Corp. | NKB | Class II | 2007-11-19 |
| K072740 | MONDEAL EXTREMITY BONE FIXATION SYSTEM | Mondeal Medical Systems GmbH | HRS | Class II | 2007-11-19 |
| K071535 | BIOLOX DELTA CERAMIC FEMORAL HEAD | Zimmer, Inc. | LZO | Class II | 2007-11-19 |
| K072101 | RIGI-FIX HIP STEM SYSTEM | Implants Intl. , Ltd. | LPH | Class II | 2007-11-19 |
| K063050 | CAP PLUS | Etex Corp. | MQV | Class II | 2007-11-19 |
| K072818 | PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS | Smith & Nephew, Inc. | HRS | Class II | 2007-11-19 |
| K071921 | INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS) | Innovasis, Inc. | NKB | Class II | 2007-11-16 |
| K071890 | ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM | Alphatec Spine, Inc. | MNH | Class II | 2007-11-09 |
| K071413 | HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM | Arthrosurface, Inc. | KRR | Class II | 2007-11-09 |
| K071724 | LUCENT | Spinal Elements, Inc. | MAX | Class II | 2007-11-09 |
| K071059 | DEPUY SPA POROUS COATED PROXIMAL SLEEVE | DePuy Orthopaedics, Inc. | KWZ | Class II | 2007-11-09 |
| K071813 | MASTERGRAFT PUTTY | Medtronic Sofamor Danek | MQV | Class II | 2007-11-09 |
| K062607 | POLYGRAFT BGS | Smith & Nephew, Inc. | MQV | Class II | 2007-11-09 |
| K072250 | SUPERCABLE GRIP AND PLATE SYSTEM | Kinamed, Inc. | KTT | Class II | 2007-11-09 |
| K072586 | CONFORMIS UNI-CONDYLAR KNEE SYSTEM | Conformis, Inc. | HSX | Class II | 2007-11-08 |
| K072710 | NEXFIX COMPRESSION PIN | Nexa Orthopedics, Inc. | JDW | Class II | 2007-11-08 |
| K071151 | TENSION BAND ANTERIOR SPINAL SYSTEM | Spinal Instrumentation Simplification Systems, LLC | KWQ | Class II | 2007-11-07 |
| K072423 | 4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY. | DePuy Orthopaedics, Inc. | HRS | Class II | 2007-11-07 |
| K072336 | REGENEREX POROUS TITANIUM SLEEVE AUGMENTS | Biomet Manufacturing Corp | JWH | Class II | 2007-11-05 |
| K072848 | ACTIVASCREW | Bioretec, Ltd. | HWC | Class II | 2007-11-02 |
| K070874 | ARTHRO KINETICS VESALIUS MR GENERATOR, MODELS 2004-2006; ACCESSORIES FOR MR GENERATOR | Arthro Kinetics, Inc. | HRX | Class II | 2007-11-02 |
| K072436 | MEGA SPINE SYSTEM | Bk Meditech, Co., Ltd. | MNI | Class II | 2007-11-01 |
| K071416 | PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM | Medtronic Sofamor Danek USA, Inc. | KWQ | Class II | 2007-11-01 |
| K072289 | SPINEFRONTIER DORADO VBR | Spinefrontier, Inc. | MAX | Class II | 2007-11-01 |
| K071912 | APACERAM BONE GRAFT SUBSTITUTE | Pentax Corp. | MQV | Class II | 2007-10-29 |
| K071990 | VALEO CERVICAL PLATE SYSTEM | Amedica Corp. | KWQ | Class II | 2007-10-29 |
| K072298 | BIOPRO MEMORY STAPLE, MODELS 18062-18073 | Biopro, Inc. | JDR | Class II | 2007-10-29 |
| K072063 | KFX TISSUE FIXATION SYSTEM AND ACCESSORIES | Kfx Medical | MBI | Class II | 2007-10-26 |
| K072083 | SMALL FRAGMENT LOCKING PLATING SYSTEM | DePuy Orthopaedics, Inc. | HRS | Class II | 2007-10-25 |
| K072706 | MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MICROPOWER ORALMAX HIGH SPEED DRILL | Conmed Linvatec | HRX | Class II | 2007-10-24 |
| K072327 | CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON | Regeneration Technologies, Inc. | MQV | Class II | 2007-10-24 |
| K072081 | ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM | Alphatec Spine, Inc. | KWP | Class II | 2007-10-24 |
| K072636 | A-BSM BONE SUBSTITUTE MATERIAL | Etex Corp. | MQV | Class II | 2007-10-23 |
| K071271 | BIOMET CABLE SYSTEM | Biomet Manufacturing, Inc. | JDQ | Class II | 2007-10-23 |
| K071726 | ZUMA | Seaspine, Inc. | MQP | Class II | 2007-10-23 |
| K071046 | SYNTHES CHRONOS COMPOSITE | Synthes (Usa) | MQV | Class II | 2007-10-23 |
| K071833 | MOSAIC DEVICES | Spinal Elements, Inc. | OVE | Class II | 2007-10-23 |
| K072426 | ATLAS SPINE PEDICLE SCREW SYSTEM | Atlas Spine, LLC | NKB | Class II | 2007-10-19 |
| K072685 | NGARDE SYSTEM | N Spine, Inc. | NQP | Class II | 2007-10-19 |
| K072339 | NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM | Nuvasive, Inc. | KWQ | Class II | 2007-10-19 |
| K072020 | RESTORATION ADM SYSTEM | Howmedica Osteonics Corp. | MEH | Class II | 2007-10-18 |
| K071948 | AEQUALIS REVERSED ADAPTER | Tornier | PHX | Class II | 2007-10-18 |
| K070530 | MODIFICATION TO PASSMED SPINAL SYSTEM | Medicrea Technologies | MNH | Class II | 2007-10-18 |
| K072597 | PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT | Wrightmedicaltechnologyinc | MQV | Class II | 2007-10-15 |
| K062447 | TRAVERSE OCT SPINAL FIXATION SYSTEM | Medtronic Sofamor Danek, Inc. | KWP | Class II | 2007-10-15 |
| K072221 | MODIFICATION TO TRIATHLON TS KNEE SYSTEM | Howmedica Osteonics Corp. | JWH | Class II | 2007-10-15 |
| K070751 | ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY | Isotis Orthobiologics, Inc. | MQV | Class II | 2007-10-15 |
| K072675 | SMITH & NEPHEW ARTHROSCOPE | Smith & Nephew, Inc. | HRX | Class II | 2007-10-15 |
| K072029 | PHENIX VERTEBRAL BODY REPLACEMENT | New Business Development, LLC | MQP | Class II | 2007-10-15 |
| K071914 | MERCURY SPINAL SYSTEM | Spinal Elements, Inc. | NKB | Class II | 2007-10-12 |
| K070955 | ACID ETCHED LAG SCREWS | Biomet Orthopedics, Inc. | HSB | Class II | 2007-10-12 |
| K072187 | PIONEER LOWTOP SPINAL ROD SYSTEM | Pioneer Surgical Technology | MNI | Class II | 2007-10-12 |
| K072253 | SYNFIX-LR SPACER | Synthes Spine Co.Lp | OVD | Class II | 2007-10-12 |
| K070773 | AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR | Axya Medical, Inc. | MBI | Class II | 2007-10-11 |
| K072120 | PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE | Innovative Spinal Technologies, Inc. | MAX | Class II | 2007-10-11 |
| K070998 | INION BIORESTORE | Inion OY | MQV | Class II | 2007-10-11 |
| K071881 | TRIATHLON PKR SYSTEM | Howmedica Osteonics Corp. | HRY | Class II | 2007-10-09 |
| K072496 | MODIFICATION TO SPACE CPSXL BONE CEMENT | Dfine, Inc. | NDN | Class II | 2007-10-05 |
| K071160 | REFLECTION, TANDEM UNIPOLAR | Smith & Nephew, Inc. | LPH | Class II | 2007-10-05 |
| K072568 | MODIFICATION TO OASYS SYSTEM | Stryker Spine | KWP | Class II | 2007-10-05 |
| K072546 | SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM | Depuy Spine, Inc. | KWQ | Class II | 2007-10-05 |
| K071880 | Optima ZS Transition Screw | Zimmer Spine, Inc. | MNI | Class II | 2007-10-05 |
| K070592 | SMALL BONE WEDGE | Wrightmedicaltechnologyinc | HRS | Class II | 2007-10-05 |
| K071879 | ZIMMER DTO IMPLANT | Zimmer Spine, Inc. | NQP | Class II | 2007-10-05 |
| K072465 | NIKO CORPECTOMY SPACER | Globus Medical, Inc. | MQP | Class II | 2007-10-04 |
| K072429 | MODIFICATION TO TSRH SPINAL SYSTEM | Medtronic Sofamor Danek | NKB | Class II | 2007-09-28 |
| K071830 | DEPUY DELTA TS CERAMIC FEMORAL HEADS | DePuy Orthopaedics, Inc. | LZO | Class II | 2007-09-28 |
| K072095 | SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS | Synthes (Usa) | JDS | Class II | 2007-09-27 |
| K063637 | RELIANCE VBS SYSTEM | Reliance Medical Systems, LLC | MQP | Class II | 2007-09-27 |
| K072355 | OSSIFUSE BONE SUBSTITUTE MATERIAL | Etex Corp. | MQV | Class II | 2007-09-26 |
| K072384 | MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE | Kensey Nash Corp. | MQV | Class II | 2007-09-21 |
| K070276 | MODIFICATION TO PASSMED SPINAL SYSTEM | Medicrea Technologies | MNI | Class II | 2007-09-21 |
| K071945 | S4 SPINAL SYSTEM | Aesculap Implant Systems | NKB | Class II | 2007-09-20 |
| K072368 | CONFORMIS METAL BACKED TIBIAL COMPONENT | Conformis, Inc. | HSX | Class II | 2007-09-20 |
| K072161 | BIOMET FEMORAL LOCKING NAIL SYSTEM | Biomet Manufacturing Corp | HSB | Class II | 2007-09-20 |
| K071816 | HARPOON SUTURE ANCHOR | Biomet Sports Medicine, Inc. | HWC | Class II | 2007-09-20 |
| K070922 | MODIFICATION TO SPINAL USA VBR SYSTEM | Spinal USA | KWQ | Class II | 2007-09-19 |
| K071071 | CROSSLINKED POLYETHYLENE ARTICULAR INSERTS | Smith & Nephew, Inc. | JWH | Class II | 2007-09-19 |
| K070387 | EXPEDIUM SPINE SYSTEM | Depuy Spine, Inc. | NKB | Class II | 2007-09-18 |
| K071922 | INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC | Rsb Spine, LLC | OVD | Class II | 2007-09-18 |
| K072317 | MODIFICATION TO:TSRH SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | NKB | Class II | 2007-09-18 |
| K072184 | VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE | Orthovita, Inc. | MQV | Class II | 2007-09-18 |
| K071428 | INQU | Isto Technologies, Inc. | MQV | Class II | 2007-09-17 |
| K070897 | BONEMEDIK, AND BONEMEDIK-S | Meta Biomed Co., Ltd. | MQV | Class II | 2007-09-17 |
17,115 clearances in the Orthopedic panel. Data: openFDA.