Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 34
- Latest Decision
- 2007-07-09
Clearances · page 97 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K071395 | BIOMET VISION FOOTRING SYSTEM | Biomet Manufacturing Corp | KTT | Class II | 2007-07-09 |
| K071639 | QWIX POSITIONING SCREW | Newdeal Sas | HWC | Class II | 2007-07-09 |
| K071107 | GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON | Zimmer, Inc. | MBH | Class II | 2007-07-06 |
| K071743 | PILLAR PEDICLE SCREW SYSTEM | The 4th Column, LLC | MNI | Class II | 2007-07-06 |
| K070978 | ZIMMER SEGMENTAL SYSTEM | Zimmer, Inc. | KRO | Class II | 2007-07-03 |
| K070973 | QUANTUM SPINAL SYSTEM | Pioneer Surgical Technology | NKB | Class II | 2007-07-03 |
| K071155 | MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER | Science For Biomaterials | MQV | Class II | 2007-07-03 |
| K071569 | ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER | Biomet, Inc. | MBI | Class II | 2007-07-02 |
| K071053 | RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD | Biomet, Inc. | KXA | Class II | 2007-06-29 |
| K071497 | ATLAS SPINE VERTEBRAL BODY REPLACEMENT | Atlas Spine, Inc. | MQP | Class II | 2007-06-29 |
| K071090 | TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION | Zimmer Trabecular Metal Technology | KWS | Class II | 2007-06-29 |
| K071394 | MODIFICATION TO:SBI RINGFIX | Small Bone Innovations, Inc. | KTT | Class II | 2007-06-29 |
| K071257 | MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD | Depuy Mitek, A Johnson & Johnson Company | JDR | Class II | 2007-06-29 |
| K070351 | SPACE 360 DELIVERY SYSTEM | Dfine, Inc. | NDN | Class II | 2007-06-29 |
| K071495 | EXPEDIUM 4.5MM SPINE SYSTEM | Depuy Spine, A Johnson & Johnson Company | NKB | Class II | 2007-06-29 |
| K071177 | ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW | Arthrex, Inc. | HWC | Class II | 2007-06-29 |
| K063670 | MODIFICATIONS TO CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek | NKB | Class II | 2007-06-28 |
| K070786 | X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT | Theken Spine, LLC | MQP | Class II | 2007-06-28 |
| K062630 | OSSIPRO BONE SUBSTITUTE MATERIAL | Etex Corp. | MQV | Class II | 2007-06-28 |
| K070849 | DEPUY GCK FEMORAL AND TIBIAL COMPONENTS | DePuy Orthopaedics, Inc. | NPJ | Class II | 2007-06-26 |
| K063393 | SMALL STATURE SPACERS | Biomet Spine | MQP | Class II | 2007-06-25 |
| K071184 | SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM | Synthes (Usa) | HRS | Class II | 2007-06-22 |
| K070995 | ARX-LINK CROSS CONNECTOR | Life Spine | NKB | Class II | 2007-06-22 |
| K071064 | ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA | Ascension Orthopedics, Inc. | HSD | Class II | 2007-06-22 |
| K070617 | CANNULATED SCREW | Fournitures Hospitalieres Industrie | HWC | Class II | 2007-06-14 |
| K070444 | AOS TIBIAL NAIL | Advanced Orthopaedic Solutions, Inc. | HSB | Class II | 2007-06-14 |
| K070933 | LOWTOP PEDICLE SCREW SYSTEM | Sanacor | MNH | Class II | 2007-06-13 |
| K071376 | MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM | Vertebron, Inc. | NKB | Class II | 2007-06-13 |
| K071372 | MODIFICATION TO: INTERPLATE VBR SYSTEM | Rsb Spine, LLC | MQP | Class II | 2007-06-11 |
| K070460 | ALLEZ SPINE CROSS CONNECTORS | Allez Spine, LLC | NKB | Class II | 2007-06-11 |
| K070281 | ISSYS LP SPINAL FIXATION SYSTEM | Custom Spine, Inc. | NKB | Class II | 2007-06-11 |
| K070891 | ALTIVA CLASSIC ACP SYSTEM | Altiva Corp. | KWQ | Class II | 2007-06-11 |
| K070573 | SYNAPSE SYSTEM | Synthes Spine Co.Lp | MNI | Class II | 2007-06-08 |
| K070695 | ZIMMER PATELLOFEMORAL JOINT PROSTHESIS | Zimmer, Inc. | KRR | Class II | 2007-06-07 |
| K063685 | OPTECURE; OPTECURE + CCC | Exactech, Inc. | MBP | Class II | 2007-06-07 |
| K061956 | ARTELON STT SPACER | Artimplant AB | KYI | Class II | 2007-06-07 |
| K070756 | SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM | Smith & Nephew, Inc. | MBL | Class II | 2007-06-06 |
| K070946 | SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIUS PLATES | Synthes (Usa) | HRS | Class II | 2007-06-06 |
| K071220 | COLUMBUS TOTAL KNEE SYSTEM AS | Aesculap Implant Systems, Inc. | JWH | Class II | 2007-06-01 |
| K061954 | ARTELON CMC SPACER ARTHRO | Artimplant AB | KYI | Class II | 2007-06-01 |
| K071237 | COPIOS BONE VOID FILLER SPONGE AND PASTE | Kensey Nash Corp. | MQV | Class II | 2007-06-01 |
| K070864 | BONEPLAST QS CALCIUM SULFATE BONE VOID FILLER | Biomet Osteobiologics | MQV | Class II | 2007-06-01 |
| K070095 | TRIATHLON TS KNEE SYSTEM | Howmedica Osteonics Corp. | JWH | Class II | 2007-06-01 |
| K071206 | ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE | Apatech , Ltd. | MQV | Class II | 2007-05-31 |
| K070382 | VISTA -S DEVICE | Zimmer Trabecular Metal Technology | MQP | Class II | 2007-05-30 |
| K061385 | OSSTAPLE, OSSPLATE, OSSFORCE | Biomedical Enterprises, Inc. | KWQ | Class II | 2007-05-30 |
| K070793 | SBI DISTAL RADIUS VOLAR PLATING SYSTEM | Small Bone Innovations, Inc. | HRS | Class II | 2007-05-30 |
| K070638 | THEKEN ATOLL CERVICO-THORACIC SYSTEM | Theken Spine, LLC | KWP | Class II | 2007-05-30 |
| K061943 | ANATOMICA POSTERIOR CERVICAL FIXATION SYSTEM | Anatomica AB | KWP | Class II | 2007-05-25 |
| K070561 | KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES | Teleflex Medical | HTY | Class II | 2007-05-25 |
| K071243 | METAL HEMI IMPLANT | Orthopro, LLC | KWD | Class II | 2007-05-23 |
| K070050 | VITALITY HIP SYSTEM MODEL#420 | Encore Medical L.P. | LPH | Class II | 2007-05-23 |
| K070295 | SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM | Trinity Orthopedics, LLC | MNI | Class II | 2007-05-21 |
| K063668 | ROC LUMBAR SYSTEM | Alphatec Spine, Inc. | MNI | Class II | 2007-05-18 |
| K071117 | MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS | DePuy Orthopaedics, Inc. | KWZ | Class II | 2007-05-18 |
| K070565 | COFIELD TOTAL SHOULDER SYSTEM | Smith & Nephew, Inc. | MBF | Class II | 2007-05-18 |
| K070688 | NEXFIX COMPRESSION STAPLE | Nexa Orthopedics, Inc. | JDR | Class II | 2007-05-18 |
| K071091 | MODIFICATION TO BILOK SCREW | Biocomposites, Ltd. | HWC | Class II | 2007-05-17 |
| K071115 | MODIFICATION TO BILOK ST SCREW | Biocomposites, Ltd. | HWC | Class II | 2007-05-17 |
| K070758 | STRYKER PEEK ZIP SUTURE ANCHOR | Stryker Endoscopy | MBI | Class II | 2007-05-16 |
| K063764 | SOUTHERN SPINE ANTERIOR CERVICAL STABILIZATION SYSTEM, KWIK- FIX CERVICAL SYSTEM, AND KWIK-FIX / TS CERVICAL SYSTEM | Southern Spine, LLC | KWQ | Class II | 2007-05-16 |
| K070724 | IOS EXTERNAL FIXATOR, MODEL 2-0-0 | Intelligent Orthopaedics, Ltd. | KTT | Class II | 2007-05-16 |
| K070885 | UNIVERSAL TAPER DELTA FEMORAL HEAD | Howmedica Osteonics Corp. | LZO | Class II | 2007-05-16 |
| K070908 | SMITH & NEPHEW KINSA RC SUTURE ANCHOR | Smith & Nephew Inc., Endoscopy Division | MBI | Class II | 2007-05-16 |
| K070347 | ALLOFIX PUSH-IN ANCHOR | Musculoskeletal Transplant Foundation | HWC | Class II | 2007-05-11 |
| K070883 | DURACON X3 CS TIBIAL INSERT | Howmedica Osteonics Corp. | MBH | Class II | 2007-05-11 |
| K071092 | ASNIS MICRO CANNULATED SCREW | Howmedica Osteonics Corp. | HWC | Class II | 2007-05-11 |
| K063584 | STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937 | Regeneration Technologies, Inc. | HWC | Class II | 2007-05-09 |
| K070994 | EAGLE + ANTERIOR CERVICAL PLATE SYSTEM | Depuy Spine, Inc. | KWQ | Class II | 2007-05-09 |
| K070437 | PRO-DENSE BONE VOID FILLER | Wrightmedicaltechnologyinc | MQV | Class II | 2007-05-09 |
| K070441 | METASURG SUBTALAR IMPLANT | Metasurg | HWC | Class II | 2007-05-08 |
| K070823 | GROWTH CONTROL PLATING SYSTEM | Biomet Trauma | HRS | Class II | 2007-05-07 |
| K070681 | NEXT GENERATION ANTERIOR CERVICAL PLATING SYSTEM | Alphatec Spine, Inc. | KWQ | Class II | 2007-05-04 |
| K070963 | REUNION HA FRACTURE STEM | Howmedica Osteonics Corp. | HSD | Class II | 2007-05-04 |
| K070368 | TRIO PLATE SYSTEM, TRIO SPINAL FIXATION SYSTEM, TRIO+ SPINAL SYSTEM | Stryker Corp. | NKB | Class II | 2007-05-04 |
| K070393 | LAGWIRE SYSTEM | Fxdevices | HWC | Class II | 2007-05-04 |
| K070399 | 100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES | Biomet Manufacturing, Inc. | JDI | Class II | 2007-05-04 |
| K070527 | ARCUATE VERTEBRAL AUGMENTATION SYSTEM | Medtronic Sofamor Danek | NDN | Class II | 2007-05-04 |
| K070229 | RANGE SPINAL SYSTEM | K2m, Inc. | MNI | Class II | 2007-05-03 |
| K070364 | 100KGY E-POLY MAXROM ACETABULAR LINERS | Biomet, Inc. | JDI | Class II | 2007-05-03 |
| K070925 | MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR | Depuy Mitek, A Johnson & Johnson Company | MAI | Class II | 2007-05-02 |
| K070843 | SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM | Synthes (Usa) | HSB | Class II | 2007-05-02 |
| K070906 | MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS | Zimmer, Inc. | HWC | Class II | 2007-05-01 |
| K070178 | AESCULAP RESORBABLE PIN, MODEL FR735 | Aesculap Implant System, Inc. | MAI | Class II | 2007-04-30 |
| K070292 | DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS | Zimmer GmbH | KXA | Class II | 2007-04-26 |
| K070381 | THEKEN VU MESH VBR SYSTEM | Theken Spine, LLC | MQP | Class II | 2007-04-25 |
| K063708 | 4S SPINAL SYSTEM | Taeyeon Medical Co., Ltd. | MNI | Class II | 2007-04-24 |
| K070082 | XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY | Vertebration,Inc | MQP | Class II | 2007-04-20 |
| K070775 | MODIFICATION TO: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEM | Globus Medical, Inc. | KWQ | Class II | 2007-04-19 |
| K070316 | INTERPLATE VBR SYSTEM | Rsb Spine, LLC | MQP | Class II | 2007-04-19 |
| K070181 | SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX | Sintea Biotech, Inc. | MQP | Class II | 2007-04-18 |
| K063346 | PRO OSTEON 500R | Ebi, L.P. | MQV | Class II | 2007-04-18 |
| K063359 | INQU | Isto Technologies, Inc. | MQV | Class II | 2007-04-16 |
| K070335 | SIMPLEX CERVICAL FIXATION SYSTEM | Pisharodi Surgicals, Inc. | KWQ | Class II | 2007-04-16 |
| K070227 | OPUS MAGNUM PI KNOTLESS FIXATION DEVICE | Arthrocare Corp. | MBI | Class II | 2007-04-16 |
| K070278 | POLARCUP DUAL MOBILITY SYSTEM | Plus Orthopedics AG | LPH | Class II | 2007-04-16 |
| K063606 | MODIFICATION TO STAXX FX SYSTEM | Spine Wave, Inc. | OBL | Class II | 2007-04-13 |
| K070220 | OSTEOFIX BONE VOID FILLER | Calcitec, Inc. | MQV | Class II | 2007-04-12 |
| K070367 | ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM | Endius, Inc. | NKB | Class II | 2007-04-12 |
| K070167 | ENDOBUTTON DIRECT | Smith & Nephew Inc., Endoscopy Division | MBI | Class II | 2007-04-12 |
17,115 clearances in the Orthopedic panel. Data: openFDA.