Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 31
- Latest Decision
- 2015-08-21
Clearances · page 55 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K143692 | GranOSTM - beta tricalcium phosphate synthetic bone granules | Tcm Associates, Ltd. | MQV | Class II | 2015-08-21 |
| K152045 | SALVATION® External Fixation System | Wrightmedicaltechnologyinc | KTT | Class II | 2015-08-21 |
| K151422 | Reform Pedicle Screw System | Precision Spine, Inc. | NKB | Class II | 2015-08-21 |
| K150481 | Cascadia Interbody System | K2m, Inc. | MAX | Class II | 2015-08-20 |
| K151346 | Frontier Medical Devices Posterior Cable Screw System | Frontier Medical Devices, Inc. | JDQ | Class II | 2015-08-20 |
| K151741 | HA Minuteman G3 MIS Fusion Plate | Spinal Simplicity, LLC | PEK | Class II | 2015-08-20 |
| K150648 | Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm | Arthrex, Inc. | MBI | Class II | 2015-08-20 |
| K150621 | OsteoSelect PLUS Demineralized Bone Matrix Putty | Bacterin International, Inc. | MQV | Class II | 2015-08-18 |
| K151140 | LnK Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | MAX | Class II | 2015-08-18 |
| K151172 | MASTERGRAFT Contain | Medtronic Sofamor Danek USA, Inc. | MQV | Class II | 2015-08-14 |
| K151277 | Airlock® osteosynthesis plate system | Novastep | HRS | Class II | 2015-08-13 |
| K151316 | U2 Hip Stem, Ti Porous Coated, Matrix | United Orthopedic Corporation | LPH | Class II | 2015-08-13 |
| K151379 | Conventus PRS System | Conventus Orthopaedics, Inc. | HRS | Class II | 2015-08-13 |
| K150847 | Foundation Interbody Devices | Corelink, LLC | ODP | Class II | 2015-08-13 |
| K151448 | Continuum and Trilogy Integrated Taper (IT) Acetabular Systems | Zimmer, Inc. | LPH | Class II | 2015-08-13 |
| K151056 | Aesculap T-Space PEEK and XP Spinal System | Aesculap Implant Systems, LLC | MAX | Class II | 2015-08-13 |
| K151462 | SI-TECHNOLOGY® SI-DESIS® SCREWS | Si-Technology, LLC | OUR | Class II | 2015-08-12 |
| K151407 | RECON system | Normed Medizin-Technik GmbH | HRS | Class II | 2015-08-12 |
| K151064 | Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System | Biomet Spine | OVE | Class II | 2015-08-12 |
| K151256 | Arthrex BioSync® Bone Wedge | Arthex, Inc. | PLF | Class II | 2015-08-12 |
| K151216 | Everest Spinal System | K2m, Inc. | NKB | Class II | 2015-08-10 |
| K151057 | WASTON Metallic Bone Plate and Screw Systems | Changzhou Waston Medical Appliance Co., Ltd. | HRS | Class II | 2015-08-10 |
| K150928 | Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides | Materialise NV | JWH | Class II | 2015-08-10 |
| K151264 | Restoration Anatomic Shell | Stryker Orthopaedics | LPH | Class II | 2015-08-10 |
| K150395 | Omega LIF System | Amendia, Inc. | MAX | Class II | 2015-08-10 |
| K151241 | Synchro-Medical TIGER TRACK Screw System | Synchro Medical | HWC | Class II | 2015-08-07 |
| K151863 | Precision Spine Interspinous Plate System | Precision Spine, Inc. | PEK | Class II | 2015-08-07 |
| K151374 | NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System | Nu Vasive, Incorporated | MAX | Class II | 2015-08-06 |
| K151128 | CAPSTONE Spinal System, CLYDESDALE Spinal System | Medtronic Sofamor Danek USA, Inc. | MAX | Class II | 2015-08-06 |
| K151235 | Medline Foot Plates and Screws | Medline Industries, Inc. | HRS | Class II | 2015-08-06 |
| K151897 | MultiFIX® P Knotless Fixation Device | ArthroCare Corporation | MBI | Class II | 2015-08-06 |
| K151879 | VariAx 2 One-Third Tubular Plating System | Stryker GmbH | HRS | Class II | 2015-08-06 |
| K151818 | SImmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | OUR | Class II | 2015-08-05 |
| K150871 | ForeFoot STP System | Tornier, Inc. | HWC | Class II | 2015-08-04 |
| K142943 | Metallic Locking Bone Plate and Screw | Canwell Medical Co., Ltd. | HRS | Class II | 2015-08-03 |
| K151813 | Sniper Spine System | Spine Wave, Inc. | MNI | Class II | 2015-07-31 |
| K151483 | Biomet Spine Fusion System | Biomet Spine, LLC | MAX | Class II | 2015-07-31 |
| K143278 | LnK Posterior Cervical Fixation System | L&K BIOMED Co., Ltd. | KWP | Class II | 2015-07-29 |
| K150759 | Hyper-C Anterior Cervical Plate System | Degen Medical | KWQ | Class II | 2015-07-28 |
| K151105 | Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteoraptor Suture Anchor, Smith and Nephew Suture Anchors - Twinfix Ultra HA Suture Anchor, Smith and Nephew Suture Anchors - OSTEORAPTOR Curved Suture Anchors, Smith and Nephew Suture Anchors - Ultra Fast-Fix Meniscal Repair System, Ultra Fa | Smith & Nephew, Inc. | MAI | Class II | 2015-07-28 |
| K151010 | Piccolo Composite Nailing System | CarboFix Orthopedics , Ltd. | HSB | Class II | 2015-07-28 |
| K150394 | Tyber Medical Wedge System | Tyber Medical, LLC | PLF | Class II | 2015-07-28 |
| K150715 | 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors | Tornier, Inc. | MBI | Class II | 2015-07-28 |
| K151118 | Smith and Nephew Legion Hinge Knee System | Smith & Nephew | KRO | Class II | 2015-07-28 |
| K151146 | N-Force Fixation System | Innovision, Inc. | HWC | Class II | 2015-07-24 |
| K151068 | SureLock W Suture Anchor | Cayenne Medical, Inc. | MBI | Class II | 2015-07-24 |
| K151532 | KYPHON ELEMENT Inflatable Bone Tamp | Medtronic, Inc. | HRX | Class II | 2015-07-23 |
| K151314 | CinchLock Flex Knotless Suture Anchor | Pivot Medical | MBI | Class II | 2015-07-23 |
| K150875 | iFuse Implant System | SI-BONE, Inc. | OUR | Class II | 2015-07-22 |
| K143143 | PATHWAY ELIF | Custom Spine, Inc. | MAX | Class II | 2015-07-22 |
| K151020 | Rampart-T Interbody Fusion System | Spineology, Inc. | MAX | Class II | 2015-07-22 |
| K150066 | Exactech Alteon Monobloc Revision Stem | Exactech, Inc. | LZO | Class II | 2015-07-20 |
| K151654 | PROW FUSION | Nlt Spine, Ltd. | MAX | Class II | 2015-07-17 |
| K150380 | ProMIS Fixation System | Premia Spine, Ltd. | NKB | Class II | 2015-07-17 |
| K151198 | A-CIFT SoloFuse | Spinefrontier, Inc. | OVE | Class II | 2015-07-17 |
| K150850 | Refobacin Bone Cement R | Biomet, Inc. | MBB | Class II | 2015-07-16 |
| K151660 | MultiFIX S Knotless Fixation System | ArthroCare Corporation | MBI | Class II | 2015-07-16 |
| K151418 | Monster Screw System | Paragon 28 | HWC | Class II | 2015-07-15 |
| K151677 | LnK Cervical Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | ODP | Class II | 2015-07-15 |
| K150700 | ACP 1 Anterior Cervical Plating System | Stryker Corporation | KWQ | Class II | 2015-07-15 |
| K151021 | OsteoMed Cannulated Screw System | Osteomed Corp. | HWC | Class II | 2015-07-15 |
| K150983 | Pyrenees Cervical Plate System | K2m | KWQ | Class II | 2015-07-14 |
| K151196 | Nautilus Spinal System | Life Spine, Inc. | NKB | Class II | 2015-07-14 |
| K151184 | InFill Interbody Fusion Devices | Pinnacle Spine Group, LLC | MAX | Class II | 2015-07-14 |
| K150321 | EVOS Lumbar Interbody System | Cutting Edge Spine, LLC | MAX | Class II | 2015-07-13 |
| K150834 | Atrax Anterior Cervical Plating System | X-Spine Systems, Inc. | KWQ | Class II | 2015-07-10 |
| K143355 | The Simple Locking IntraMedullary (SLIM) System | Pega Medical, Inc. | HSB | Class II | 2015-07-10 |
| K142005 | SpineFab Vertebral Body Replacement (VBR) System | Oxford Performance Materials | MQP | Class II | 2015-07-10 |
| K151143 | EndoLIF On-Cage | Joimax GmbH | MAX | Class II | 2015-07-09 |
| K150655 | OIC Intramedullary Nail System | Orthopaedic Implant Company | HSB | Class II | 2015-07-09 |
| K151755 | OASYS(r) System | Stryker Corporation | NKG | Class II | 2015-07-09 |
| K151037 | GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle | Conmed Corporation | MBI | Class II | 2015-07-09 |
| K151581 | Leva Spacer System | Spine Wave, Inc. | MAX | Class II | 2015-07-09 |
| K141725 | BONGOLD BONE GRAFT MATERIAL | Beijing Allgens Medical Science & Technology Co, L | MQV | Class II | 2015-07-09 |
| K151488 | Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System | Orthofix, Inc. | NKB | Class II | 2015-07-07 |
| K150661 | ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite | Citieffe S.R.L. | JDW | Class II | 2015-07-07 |
| K150856 | Reform Pedicle Screw System | Precision Spine, Inc. | NKB | Class II | 2015-07-07 |
| K143745 | Arthrex Corkscrew and SwiveLock Suture Anchors | Arthrex, Inc. | MBI | Class II | 2015-07-02 |
| K143271 | CastleLoc-P Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | KWQ | Class II | 2015-07-01 |
| K150889 | Suture Wires and Wire Loops | Zimmer, Inc. | JDQ | Class II | 2015-07-01 |
| K143688 | ASFORA ANTERIOR CERVICAL PLATE SYSTEM | Medical Designs, LLC | KWQ | Class II | 2015-07-01 |
| K151224 | Lineum OCT Spine System | Biomet Spine | NKG | Class II | 2015-06-30 |
| K141680 | AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws | Auxein Medical | HRS | Class II | 2015-06-30 |
| K151201 | Stryker ICONIX with Needles | Stryker | MBI | Class II | 2015-06-29 |
| K151116 | CapLOX II/TowerLOX Pedicle Screw System | Captiva Spine | MNH | Class II | 2015-06-26 |
| K150680 | Freedom Cementless Femoral Component | Maxx Orthopedics, Inc. | MBH | Class II | 2015-06-26 |
| K142814 | Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial | Biomet Manufacturing, LLC | JDI | Class II | 2015-06-25 |
| K151214 | ALIF Interfixated System | Nu Vasive, Incorporated | OVD | Class II | 2015-06-25 |
| K151178 | VariAx 2 Wrist Fusion System | Stryker Trauma AG | HRS | Class II | 2015-06-24 |
| K151031 | Virage OCT Spinal Fixation System | Zimmer Spine, Inc. | NKG | Class II | 2015-06-24 |
| K143110 | GALAXY MIS Screw System | Bm Korea | NKB | Class II | 2015-06-24 |
| K150053 | STALIF C; STALIF C-Ti | Centinel Spine, Inc. | OVE | Class II | 2015-06-24 |
| K150783 | Progressive Orthopaedic Total Knee System | The Progressive Orthopaedic Company, LLC | JWH | Class II | 2015-06-23 |
| K150981 | SMV Scientific Bone Screws | Smv Scientific | HWC | Class II | 2015-06-23 |
| K150666 | uNion Cervical Plate System | Ulrich Medical USA | KWQ | Class II | 2015-06-22 |
| K150500 | Px PEEK IBF System | Innovasis, Inc. | MAX | Class II | 2015-06-19 |
| K151230 | Arthrex FiberTak Anchors | Arthrex, Inc. | MBI | Class II | 2015-06-19 |
| K151131 | PRECICE Intramedullary Limb Lengthening System | Ellipse Technologies, Incorporated | HSB | Class II | 2015-06-19 |
| K142752 | Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System | Zimmer Spine, Inc. | NKB | Class II | 2015-06-18 |
| K151276 | DePuy Synthes T-PAL Ti Spacer | Synthes USA Products, LLC | MAX | Class II | 2015-06-18 |
17,115 clearances in the Orthopedic panel. Data: openFDA.