Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 41
- Latest Decision
- 2015-04-20
Clearances · page 57 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K150133 | PROFEMUR Preserve Size 1-3 Hip Stems | Microport Orthopedics, Inc. | LZO | Class II | 2015-04-20 |
| K150714 | SI-BONE iFuse Implant System | SI-BONE, Inc. | OUR | Class II | 2015-04-17 |
| K150416 | ProCinch Adjustable Loop Device | Stryker Endoscopy | HTY | Class II | 2015-04-17 |
| K140453 | OSTEOTEC SILICONE FINGER IMPLANT | Osteotec, Ltd. | KYJ | Class II | 2015-04-17 |
| K143731 | IMPLANET Spine System (ISS) | Implanet, S.A. | NKB | Class II | 2015-04-14 |
| K143706 | FortiBridge Anterior Cervical Plate System | Nanovis Spine, LLC | KWQ | Class II | 2015-04-10 |
| K142456 | GPS Spacers | G Surgical, LLC | ODP | Class II | 2015-04-10 |
| K150302 | PROFEMUR Preserve Classic Stem | Microport Orthopedics, Inc. | LZO | Class II | 2015-04-10 |
| K143702 | Arthrex Blunt Tip Screws with Fiber Tape | Arthrex, Inc. | HTY | Class II | 2015-04-09 |
| K150607 | Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml | Osseon, LLC | NDN | Class II | 2015-04-09 |
| K143258 | PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) | 4Web, Inc. | MAX | Class II | 2015-04-09 |
| K143659 | Equinoxe Mega Prosthesis | Exactech, Inc. | KWT | Class II | 2015-04-09 |
| K142581 | APTUS Foot System | Medartis AG | HRS | Class II | 2015-04-09 |
| K150647 | Polyscrew Pedicle Screw System | New Era Orthopedics, LLC | MNI | Class II | 2015-04-08 |
| K141737 | CONVENTUS PHS SYSTEM | Conventus Orthopaedics, Inc. | JDS | Class II | 2015-04-08 |
| K143019 | CD HORIZON Spinal System, IPC POWEREASE System | Medtronic Sofamor Danek USA, Inc. | NKB | Class II | 2015-04-08 |
| K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | KWS | Class II | 2015-04-08 |
| K143249 | SOLSTICE OCT System | Life Spine, Inc. | KWP | Class II | 2015-04-07 |
| K150229 | SOLSTICE OCT System | Life Spine, Inc. | KWP | Class II | 2015-04-07 |
| K143385 | Acumed Ankle Plating System | Acumed, LLC | HRS | Class II | 2015-04-06 |
| K143523 | Airlock osteosynthesis plate system | Novastep | HRS | Class II | 2015-04-06 |
| K150206 | InFill Interbody Fusion Devices | Pinnacle Spine Group, LLC | MAX | Class II | 2015-04-03 |
| K143749 | Arthrex Distal Radius System | Arthrex, Inc. | HRS | Class II | 2015-04-03 |
| K150507 | Santis Pedicle Screw System | Lanterna Medical Technologies | NKB | Class II | 2015-04-03 |
| K142569 | Aptis Medical Distal Radio Ulnar Joint Implant | Aptis Medical, LLC | KXE | Class II | 2015-04-03 |
| K143360 | LnK Cervical Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | ODP | Class II | 2015-04-03 |
| K142761 | Corin TaperFit Hip Stem | Corin USA | JDI | Class II | 2015-04-03 |
| K141934 | PHYSICA KR KNEE SYSTEM | Lima Corporate S.P.A. | JWH | Class II | 2015-04-02 |
| K142217 | Reliance Interspinous Plate System | Reliance Medical Systems, LLC | PEK | Class II | 2015-04-02 |
| K143165 | Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw | Zimmer, Inc. | HWC | Class II | 2015-03-31 |
| K142218 | Coalition AGX Plate and Coalition AGX Spacer | Globus Medical, Inc. | ODP | Class II | 2015-03-31 |
| K150325 | Range/Denali/Mesa Spinal System | K2m, Inc. | NKB | Class II | 2015-03-31 |
| K141527 | DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM | Synthes USA | HRS | Class II | 2015-03-30 |
| K143697 | Biomet Proximal Humerus Plating System | Biomet Manufacturing | HRS | Class II | 2015-03-30 |
| K143365 | Eminent Foot Plate System | Eminent Spine | HRS | Class II | 2015-03-30 |
| K142798 | PASS LP Spinal System | Medicrea International SA | MNH | Class II | 2015-03-25 |
| K143533 | FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE | Prosidyan, Inc. | MQV | Class II | 2015-03-25 |
| K143443 | VEGA Knee System, Columbus Total Knee System | Aesculap Implants Systems, LLC | JWH | Class II | 2015-03-25 |
| K143473 | Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.4mm with (1) size 2-0 UHMWPE suture with needles | Cayenne Medical, Inc. | MBI | Class II | 2015-03-25 |
| K142117 | INVISION TOTAL ANKLE REVISION SYSTEM | Wrightmedicaltechnologyinc | HSN | Class II | 2015-03-25 |
| K150503 | Echo Bi-Metric Microplasty Line Extension | Biomet, Inc. | LPH | Class II | 2015-03-25 |
| K141278 | MAGEC SPINAL BRACING AND DISTRACTION SYSTEM | Ellipse Technologies, Inc. | PGN | Class II | 2015-03-24 |
| K143096 | SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA | Smith & Nephew, Inc. | LZO | Class II | 2015-03-24 |
| K150368 | Tarsa-Link Wedge Fixation System | Life Spine | HRS | Class II | 2015-03-24 |
| K142649 | Progressive Orthopedic Total Knee System | The Progressive Orthopaedic Company, LLC | JWH | Class II | 2015-03-24 |
| K142776 | Flow-Screw | Flow-Fx, LLC | HWC | Class II | 2015-03-23 |
| K150099 | Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws) | Synthes (USA) Products, LLC | HRS | Class II | 2015-03-23 |
| K150469 | Integra Laminoplasty System | Seaspine, Inc. | NQW | Class II | 2015-03-23 |
| K150449 | LITe Plate System | Stryker Corp. | KWQ | Class II | 2015-03-20 |
| K150410 | RESTORIS POROUS PARTIAL KNEE SYSTEM | Mako Surgical Corporation | HRY | Class II | 2015-03-20 |
| K143158 | Xenco Medical Lumbar Interbody System | Xenco Medical, LLC | MAX | Class II | 2015-03-20 |
| K143279 | LnK Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | KWQ | Class II | 2015-03-20 |
| K142778 | ARROW Reverse Shoulder long keel and short keel glenoid base | Fournitures Hospitalieres Industrie | PHX | Class II | 2015-03-20 |
| K142531 | F1-Modular Pedicle Screw System | Degen Medical | NKB | Class II | 2015-03-20 |
| K141493 | PROXIMAL HUMERUS PLATING SYSTEM | Miami Device Solutions | HRS | Class II | 2015-03-20 |
| K143626 | inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System | Zimmer Spine, Inc. | KWQ | Class II | 2015-03-20 |
| K143717 | Treace Medical Concepts(TMC) Plating System | Treace Medical Concepts, Inc. | HRS | Class II | 2015-03-19 |
| K143184 | Evolve UniPolar Head | Signature Orthopaedics Pty, Ltd. | KWL | Class II | 2015-03-17 |
| K150390 | Nautilus Spinal System | Life Spine, Inc. | NKB | Class II | 2015-03-16 |
| K141665 | NuVasive CoRoent System | Nuvasive, Inc. | MAX | Class II | 2015-03-13 |
| K142634 | Biomet Spine Fusion System | Biomet Spine, LLC | MAX | Class II | 2015-03-12 |
| K150307 | RESTORIS Multicompartmental Knee System | Mako Surgical Corp. | NPJ | Class II | 2015-03-10 |
| K150322 | InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm) | Pan Medical , Ltd. | NDN | Class II | 2015-03-06 |
| K143100 | NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta | Cossington, Ltd. | LOD | Class II | 2015-03-05 |
| K141740 | INFINITY (TM) TOTAL ANKLE SYSTEM; INBONE TOTAL ANKLE SYSTEM | Wrightmedicaltechnologyinc | HSN | Class II | 2015-03-05 |
| K143388 | Affix IIS Spinous Process Plate System | Nu Vasive, Incorporated | PEK | Class II | 2015-03-05 |
| K150285 | Leva(TM) Spacer System | Spine Wave, Inc. | MAX | Class II | 2015-03-05 |
| K143134 | NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System | Cossington, Ltd. | LOD | Class II | 2015-03-05 |
| K143616 | AccuLIF TL and PL Cage | Stryker Corporation | MAX | Class II | 2015-03-05 |
| K143331 | Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS | Zimmer, Inc. | HRS | Class II | 2015-03-04 |
| K143725 | Consensus Knee System Modular Tibial Baseplate | Consensus Orthopedics, Inc. | JWH | Class II | 2015-03-04 |
| K150309 | Extremity Medical Calcaneal Osteotomy Device | Extremity Medical, LLC | HWC | Class II | 2015-03-04 |
| K150004 | SALVATION External Fixation System | Wrightmedicaltechnologyinc | KTT | Class II | 2015-03-04 |
| K143552 | Simpliciti Shoulder System | Tornier, Inc. | PKC | Class II | 2015-03-04 |
| K141825 | IDEAL Locking Plate System | Jiangsu Ideal Medical Science & Technology Co., LT | HRS | Class II | 2015-03-03 |
| K143453 | Mpact Double Mobility System | Medacta International | LPH | Class II | 2015-03-02 |
| K143314 | Progressive Orthopaedic Total Hip System | The Progressive Orthopaedic Company, LLC | LPH | Class II | 2015-02-27 |
| K143576 | Exactech Ambassador | Exactech, Inc. | KWQ | Class II | 2015-02-27 |
| K142119 | PROCOTYL L-O ACETABULAR SYSTEM | Microport Orthopedics, Inc. | LPH | Class II | 2015-02-27 |
| K142498 | MAGNIFY and MAGNIFY-S Spacers | Globus Medical, Inc. | OVD | Class II | 2015-02-26 |
| K143228 | Ancora LLC Interbody Fusion Device | Frontier Medical Devices, Inc. | OVD | Class II | 2015-02-26 |
| K142576 | Spinal System | Eisertech, LLC | NKB | Class II | 2015-02-26 |
| K143323 | OS2-V Varisation Staple | In2bones Sas | JDR | Class II | 2015-02-26 |
| K150200 | CD HORIZON Growth Rod Conversion Set | Medtronic Sofamor Danek USA, Incorporated | PGM | Class II | 2015-02-25 |
| K150009 | Baide | Jiangsu Baide Medical Intrument Co., Ltd. | HRS | Class II | 2015-02-25 |
| K143230 | Palladian Lumbar Pedicle Screw System | Neurostructures, Inc. | NKB | Class II | 2015-02-25 |
| K142823 | Biomet Microfixation Thoracic Fixation System | Biomet Microfixation | HRS | Class II | 2015-02-25 |
| K143417 | ANAX 5.5 Spinal System | U&I Corporation | MNH | Class II | 2015-02-25 |
| K143350 | Nile Alternative Fixation | K2m, Inc. | OWI | Class II | 2015-02-25 |
| K141429 | SORRENTO BONE GRAFT SUBSTITUTE | Haider Biologics, LLC | MQV | Class II | 2015-02-23 |
| K143214 | SCARLET® AC-T Secured Anterior Cervical Cage | Spineart | OVE | Class II | 2015-02-23 |
| K150121 | Zimmer Periarticular Plating System | Zimmer, Inc. | HRS | Class II | 2015-02-23 |
| K150166 | Extremity Medical Suture Anchor | Extremity Medical, LLC | MBI | Class II | 2015-02-23 |
| K142345 | Talos-C(HA) Cervical Intervertebral Body Fusion Devices | Meditech Spine, LLC | ODP | Class II | 2015-02-22 |
| K141246 | LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM | Life Spine, Inc. | OUR | Class II | 2015-02-22 |
| K143705 | NeedleCam HD Visualization System | Biovision Technologies, LLC | HRX | Class II | 2015-02-20 |
| K132868 | CARRICELL | Etex Corporation | MQV | Class II | 2015-02-20 |
| K143635 | KINETIS Total Knee System | Mako Surgical | JWH | Class II | 2015-02-20 |
| K142205 | NuVasive X-CORE(R) Expandable VBR System | Nuvasive, Inc. | MQP | Class II | 2015-02-20 |
| K141401 | EASY OUT | Feet For Life Podiatry Center | HWC | Class II | 2015-02-20 |
17,115 clearances in the Orthopedic panel. Data: openFDA.