Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 40
- Latest Decision
- 2016-06-01
Clearances · page 51 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K160264 | Additive Orthopaedics Hammertoe Correction System | Additive Orthopaedics, LLC | HTY | Class II | 2016-06-01 |
| K160980 | Threshold Pedicular Fixation System, Palisade Pedicular Fixation System | Spineology, Inc. | NKB | Class II | 2016-05-26 |
| K160902 | Mariner Pedicle Screw System | SeaSpine Orthopedics Corporation | NKB | Class II | 2016-05-26 |
| K153379 | AxSOS 3Ti | Stryker GmbH | HRS | Class II | 2016-05-26 |
| K161190 | G7 Dual Mobility System, Active Articulation System | Biomet, Inc. | LPH | Class II | 2016-05-26 |
| K153345 | Stryker Orthopaedics Hip Systems Labeling Update | Stryker Orthopaedics | LPH | Class II | 2016-05-25 |
| K153629 | ArcadiusXP C Spinal System | Aesculap Implant Systems, Inc. | OVE | Class II | 2016-05-25 |
| K153743 | PIEZOSURGERY PLUS | Mectron S.P.A. | JDX | Class II | 2016-05-25 |
| K160463 | Reliance Lumbar IBF System | Reliance Medical Systems, LLC | MAX | Class II | 2016-05-20 |
| K160289 | MasterLoc Stem | Medacta International | LZO | Class II | 2016-05-20 |
| K153107 | Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine VEO Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System | Choicespine, LP | MAX | Class II | 2016-05-19 |
| K160342 | EMPOWR PS Knee System | Encore Medical L.P. | JWH | Class II | 2016-05-19 |
| K161041 | OsteoMed ExtremiLOCK Wrist Plating System | Osteomed | HRS | Class II | 2016-05-19 |
| K160226 | JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector | Implanet, S.A. | NKB | Class II | 2016-05-18 |
| K161080 | Escalade Legend Acetabular Shell | Ortho Development Corporation | LPH | Class II | 2016-05-17 |
| K153716 | GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. | Gpc Medical, Ltd. | HRS | Class II | 2016-05-17 |
| K152062 | BIOFOAM Bone Wedge | Wrightmedicaltechnologyinc | HRS | Class II | 2016-05-17 |
| K152754 | COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS) | Biomet Manufacturing Corp | PHX | Class II | 2016-05-16 |
| K160154 | ALTA Anterior Cervical Interbody Spacer | Astura Medical | ODP | Class II | 2016-05-13 |
| K152825 | Catalyst CSR Shoulder System | Catalyst Orthoscience, LLC | KWT | Class II | 2016-05-11 |
| K160319 | FiberTak DR | Arthrex, Inc. | MBI | Class II | 2016-05-10 |
| K153657 | Vanguard XP Knee System | Biomet, Inc. | MBH | Class II | 2016-05-10 |
| K152431 | LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating | Waldemar Link GmbH & Co. KG | KRO | Class II | 2016-05-09 |
| K153615 | NeoFuse HA Enhanced PLIF/TLIF | Ht Medical, LLC | MAX | Class II | 2016-05-06 |
| K153008 | INVISION Total Ankle Revision System | Wrightmedicaltechnologyinc | HSN | Class II | 2016-05-06 |
| K160324 | Cervical Interbody Fusion System | Evolution Spine, LLC | ODP | Class II | 2016-05-05 |
| K160428 | Certex Spinal Fixation System | X-Spine Systems, Inc. | NKG | Class II | 2016-05-05 |
| K153585 | Flip Button Suture Anchor | First Ray, LLC | MBI | Class II | 2016-05-05 |
| K151362 | HC Spinal System | Hung Chun Bio-S Co., Ltd. | MNH | Class II | 2016-05-05 |
| K153783 | SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF | Spinevision S.A. | MAX | Class II | 2016-05-04 |
| K160568 | Precision Spine Interspinous Plate System | Precision Spine, Inc. | PEK | Class II | 2016-05-04 |
| K160986 | Xenco Medical Pedicle Screw System | Xenco Medical, LLC | NKB | Class II | 2016-05-04 |
| K153720 | ENZA Zero-Profile Anterior Interbody Fusion | Camber Spine Technologies | OVD | Class II | 2016-05-03 |
| K160118 | STROPP (Single Tunnel Repair of Plantar Plate) | Crossroads Extremity Systems, LLC | MBI | Class II | 2016-05-03 |
| K152903 | REVIVAL(TM) Modular Revision Hip Stem | Corin USA | LZO | Class II | 2016-04-29 |
| K160548 | MC-Subtalar(TM) II | Merete Medical GmbH | HWC | Class II | 2016-04-29 |
| K160304 | OsteoBullet Compression Screw | Phalanx Innovations | HWC | Class II | 2016-04-29 |
| K152084 | Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug | Corentec Co., Ltd. | LPH | Class II | 2016-04-29 |
| K153152 | Syzygy Stabilization System | Amendia, Inc. | NKB | Class II | 2016-04-27 |
| K153526 | Pyrenees Cervical Plate System | K2m | KWQ | Class II | 2016-04-27 |
| K160194 | StarFuse Interphalangeal Pin | Phalanx Innovations | HTY | Class II | 2016-04-26 |
| K153453 | Inertia Pedicle Screw and Deformity Correxxion System | Nexxt Spine, LLC | NKB | Class II | 2016-04-26 |
| K153123 | Genesys Spine Apache Interbody Fusion System | Genesys Spine | MAX | Class II | 2016-04-26 |
| K160522 | White Pearl Preferred Angle Anterior Cervical Plate | Osseus Fusion Systems, LLC | KWQ | Class II | 2016-04-26 |
| K153602 | Materialise Glenoid Positioning System | Materialise NV | KWS | Class II | 2016-04-26 |
| K160756 | PASS OCT Spinal System | Medicrea International SA | NKG | Class II | 2016-04-26 |
| K160125 | Cascadia Interbody System | K2m | ODP | Class II | 2016-04-22 |
| K160633 | G3(TM) Active Plate(R) Small Fragment System | Genesis Fracture Care, Inc. | HRS | Class II | 2016-04-22 |
| K160216 | Revolution Spinal Fixation System | Intelligent Implant Systems, LLC | NKB | Class II | 2016-04-22 |
| K153413 | PASS LP Spinal System | Medicrea International SA | NKB | Class II | 2016-04-22 |
| K160300 | MotoBand(TM) CP Implant System | Crossroads Extremity Systems, LLC | HRS | Class II | 2016-04-22 |
| K160177 | Gridlock Ankle Plating System | Trilliant Surgical, Ltd. | HRS | Class II | 2016-04-22 |
| K153737 | OSTEOPAL plus | Heraeus Medical GmbH | LOD | Class II | 2016-04-22 |
| K152077 | MaxiGen | Hans Biomed Corp. | MQV | Class II | 2016-04-21 |
| K160249 | ULTRA Telescopes | Olympus Winter & Ibe GmbH | HRX | Class II | 2016-04-21 |
| K153558 | Ventix Suture Anchor | Biomet Manufacturing Corp | MBI | Class II | 2016-04-21 |
| K153404 | Zavation Spinal System | Zavation, LLC | MNH | Class II | 2016-04-21 |
| K160500 | Elite SPK, Compasso, Elite SPK Kit | Ncs Lab Srl | MBI | Class II | 2016-04-20 |
| K160051 | NuVasive® Interfixated Interbody System | Nu Vasive, Incorporated | OVD | Class II | 2016-04-20 |
| K151527 | Arthrex Univers Revers CA Heads and Adapters | Arthrex, Inc. | HSD | Class II | 2016-04-19 |
| K153638 | Bicortical Fixation Screw & Washer Nut System | First Ray, LLC | HWC | Class II | 2016-04-19 |
| K153222 | Leva Spacer System | Spine Wave, Inc. | MAX | Class II | 2016-04-15 |
| K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer | Globus Medical, Inc. | MAX | Class II | 2016-04-13 |
| K151704 | Diplomat® Spinal System | Signus Medizintechnik GmbH | NKB | Class II | 2016-04-13 |
| K153419 | NuVasive CoRoent Thoracolumbar System | Nu Vasive, Incorporated | MAX | Class II | 2016-04-13 |
| K152430 | All Poly Tibial Component | United Orthopedic Corporation | JWH | Class II | 2016-04-12 |
| K151977 | icotec Pedicle System | Icotec AG | NKB | Class II | 2016-04-12 |
| K160461 | Arthrex iBalance BiCompartmental Arthroplasty System | Arthrex, Inc. | KRR | Class II | 2016-04-12 |
| K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty System | Arthrosurface, Inc. | KWD | Class II | 2016-04-11 |
| K153377 | Hoffmann LRF (Limb Reconstruction Frame) System | Stryker GmbH | KTT | Class II | 2016-04-11 |
| K153446 | OLYMPIC Posterior Spinal Fixation System | Astura Medical | OSH | Class II | 2016-04-08 |
| K153622 | First Ray Internal Bone Staple System | First Ray, LLC | JDR | Class II | 2016-04-08 |
| K160266 | ICONACY(TM) I-Hip(TM) | Iconacy Orthopedic Implants, LLC | LPH | Class II | 2016-04-08 |
| K152439 | U2 Bipolar Implant and 22mm Femoral Head | United Orthopedic Corporation | KWY | Class II | 2016-04-07 |
| K153722 | SMR 3-Pegs Glenoids | Lima Corporate S.P.A. | KWS | Class II | 2016-04-06 |
| K153482 | KLS Martin Thoracic Plating System | KLS-Martin L.P. | HRS | Class II | 2016-04-06 |
| K151983 | KLS Martin LSS Plating System | KLS Martin L.P. | JDQ | Class II | 2016-04-06 |
| K160325 | PRECICE Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | HSB | Class II | 2016-04-04 |
| K160124 | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System | Spinevision S.A. | MNI | Class II | 2016-04-04 |
| K160464 | Opticage(R) Expandable Interbody Fusion Device | Interventional Spine, Inc. | MAX | Class II | 2016-04-04 |
| K160320 | Premier | Shandong Weigao Orthopaedic Device Co., Ltd. | MNI | Class II | 2016-04-01 |
| K151932 | Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing | Stryker Corporation | HRX | Class II | 2016-03-31 |
| K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System | Ldr Spine USA | MAX | Class II | 2016-03-31 |
| K160267 | PRECICE Trauma Nail System | Ellipse Technologies, Incorporated | HSB | Class II | 2016-03-31 |
| K153348 | JAZZ LOCK | Implanet, S.A. | OWI | Class II | 2016-03-31 |
| K153772 | Corin TriFit TS Hip | Corin U.S.A. Limited | MEH | Class II | 2016-03-31 |
| K153042 | TRYPTIK2C-plate Anterior Cervical Plate System | Spineart | KWQ | Class II | 2016-03-28 |
| K160603 | SMV Scientific Schanz Screws | Smv Scientific | HWC | Class II | 2016-03-28 |
| K160528 | ANATOMIC PEEK PTC Cervical Fusion System | Medtronic Sofamor Danek USA, Inc. | ODP | Class II | 2016-03-28 |
| K160191 | Align Anterior Ankle Fusion Plate | Extremity Medical, LLC | HRS | Class II | 2016-03-25 |
| K153725 | Corin TaperFit Hip Stem | Corin U.S.A. Limited | JDI | Class II | 2016-03-25 |
| K153721 | iTotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | JWH | Class II | 2016-03-25 |
| K152200 | SurgTech Interbody System | Surgtech, Inc. | MAX | Class II | 2016-03-25 |
| K153595 | Optetrak Logic Metaphyseal Cones | Exactech, Inc. | JWH | Class II | 2016-03-25 |
| K151881 | X-Fix Line Additions | Vilex IN Tennessee, Inc. | KTT | Class II | 2016-03-24 |
| K151342 | Arthrex SwiveLock Anchors | Arthrex, Inc. | MAI | Class II | 2016-03-24 |
| K160547 | Cascadia Interbody System | K2m | MAX | Class II | 2016-03-24 |
| K152253 | Biomet Microfixation RibFix Blu Thoracic Fixation System | Biomet Microfixation | HRS | Class II | 2016-03-24 |
| K153667 | TRUESPAN Meniscal Repair System | Medos International SARL | MBI | Class II | 2016-03-24 |
| K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | MAX | Class II | 2016-03-24 |
17,115 clearances in the Orthopedic panel. Data: openFDA.