Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 43
- Latest Decision
- 2018-04-20
Clearances · page 41 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K180753 | SafetyFix EasyOut System | Safetyfix Medical Technologies, Inc. | HWC | Class II | 2018-04-20 |
| K180750 | World Knee System | Signature Orthopaedics Pty, Ltd. | JWH | Class II | 2018-04-20 |
| K173900 | Arthrex Univers Revers Modular Glenoid System | Arthrex, Inc. | PHX | Class II | 2018-04-20 |
| K173472 | MySpine Pedicle Screw Placement Guides MC and Drill Pilot Instruments | Medacta International S.A. | PQC | Class II | 2018-04-19 |
| K173964 | OVOMotion Shoulder Arthroplasty System | Arthrosurface, Inc. | HSD | Class II | 2018-04-18 |
| K172947 | HALF DOME Posterior Lumbar Interbody System | Astura Medical | MAX | Class II | 2018-04-18 |
| K180851 | VERTEX Reconstruction System | Medtronic Sofamor Danek USA, Inc. | NKG | Class II | 2018-04-18 |
| K173432 | ENZA-A Titanium ALIF | Camber Spine Technologies | OVD | Class II | 2018-04-18 |
| K180078 | Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System | Innovasis, Inc. | MAX | Class II | 2018-04-17 |
| K180458 | FOCUS Pedicle Screw System | Nvision Biomedical Technologies, LLC | NKB | Class II | 2018-04-17 |
| K173935 | Mediant Anterior Cervical Plating System | Intelligent Implant Systems, LLC | KWQ | Class II | 2018-04-16 |
| K173606 | SeaSpine Vu aPOD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu aPOD Prime Intervertebral Body Fusion Device | SeaSpine Orthopedics Corporation | OVD | Class II | 2018-04-13 |
| K180744 | Stablyx CMC Arthroplasty Implant System | Skeletal Dynamics, LLC | KYI | Class II | 2018-04-11 |
| K173880 | Corin TriFit CF Hip Stem | Corin U.S.A. Limited | MEH | Class II | 2018-04-11 |
| K180121 | Rafugen DBM | Cellumed Co., Ltd. | MQV | Class II | 2018-04-11 |
| K173859 | HEALIX ADVANCE Anchor with DYNACORD Suture | Medos International SARL | MAI | Class II | 2018-04-11 |
| K172495 | Reform® POCT System | Precision Spine, Inc. | NKG | Class II | 2018-04-11 |
| K180301 | AXIS 5.5 Lumbar Pedicle Screw System | Axis Orthopaedics | NKB | Class II | 2018-04-10 |
| K172206 | NAJA Ligament Correction System | Cousin Biotech Sas | OWI | Class II | 2018-04-10 |
| K172967 | Mercury® Spinal System | Spinal Elements, Inc. | NKB | Class II | 2018-04-10 |
| K173525 | NovoGro | Osteonovus, Inc. | MQV | Class II | 2018-04-06 |
| K180080 | FIBERGRAFT BG Matrix Bone Graft Substitute | Prosidyan, Inc. | MQV | Class II | 2018-04-06 |
| K173775 | Clench Compression Staple | F & A Foundation, LLC D.B.A. Reign Medical | JDR | Class II | 2018-04-06 |
| K173767 | A. L. P. S. Clavicle Plating System | Biomet, Inc. | HRS | Class II | 2018-04-06 |
| K180324 | Patriot Spinal Fixation System | Valorus Spine | NKB | Class II | 2018-04-06 |
| K173867 | Axis Anterior Cervical Plate System | Axis Orthopaedics | KWQ | Class II | 2018-04-05 |
| K180089 | Medacta Shoulder System Short Humeral Diaphysis | Medacta International S.A. | PHX | Class II | 2018-04-05 |
| K180376 | K2M Patient Specific Rods | K2m, Inc. | NKB | Class II | 2018-04-05 |
| K173074 | ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor | Stryker | MBI | Class II | 2018-04-04 |
| K173362 | DSM Biomedical Calcium Phosphate Cement | Kensey Nash Corporation Dba Dsm Biomedical | MQV | Class II | 2018-04-03 |
| K180503 | PRECICE STRYDE System | Nuvasive Specialized Orthopedics, Inc. | HSB | Class II | 2018-04-03 |
| K173506 | LigaPASS | Medicrea International SA | OWI | Class II | 2018-04-03 |
| K180243 | Infinity-Lock Button System | Xiros, Ltd. | HTN | Class II | 2018-04-03 |
| K173885 | Genesys Spine Binary Lumbar Plate System | Genesys Spine | KWQ | Class II | 2018-04-03 |
| K180210 | CREO® Stabilization System | Globus Medical, Inc. | NKB | Class II | 2018-04-02 |
| K171624 | IXOS Radius Plate System | Stuckenbrock Medizintechnik GmbH | HRS | Class II | 2018-03-29 |
| K171841 | Arthrex Shoulder System | Arthrex, Inc. | KWS | Class II | 2018-03-29 |
| K173082 | Arco-SA Lumbar Cage System | Neurostructures, Inc. | OVD | Class II | 2018-03-29 |
| K173057 | Zimmer Knee Joint Replacement Prostheses MR Labeling | Zimmer, Inc. | JWH | Class II | 2018-03-29 |
| K172235 | CoreHip® System | Aesculap Implants Systems, LLC | LZO | Class II | 2018-03-28 |
| K180056 | Genesys Spine AIS-C Cervical Anchored Interbody System | Genesys Spine | OVE | Class II | 2018-03-28 |
| K172269 | FORTRESS Radiopaque Bone Cement (FORTRESS and FORTRESS-Plus), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System | Globus Medical, Inc. | PML | Class II | 2018-03-27 |
| K171966 | Mpact® 3D Metal Implants and Augments 3D Metal | Medacta International S.A. | LPH | Class II | 2018-03-27 |
| K180537 | Zavation Buttress Plate System | Zavation Medical Products, LLC | KWQ | Class II | 2018-03-27 |
| K180315 | DISKOM | Biopsybell S.R.L. | HRX | Class II | 2018-03-26 |
| K170753 | Acculoc Total Knee System | Rootloc Co., Ltd. | JWH | Class II | 2018-03-23 |
| K172371 | Arthrex UNIVERS REVERS COATED BASEPLATE | Arthrex, Inc. | PHX | Class II | 2018-03-22 |
| K173128 | Alamo® C | Alliance Partners, LLC | ODP | Class II | 2018-03-22 |
| K180431 | Cortina [MAX] Lumbar Cage System | Neurostructures, Inc. | MAX | Class II | 2018-03-22 |
| K180274 | Ventix Link Knotless Anchor with Inserter | Cayenne Medical, Inc. | MBI | Class II | 2018-03-21 |
| K171863 | Anjon Bremer Halo System | Anjon Holdings, LLC | JEC | Class II | 2018-03-19 |
| K172148 | Anchorage Bone Plating System | Stryker GmbH | HRS | Class II | 2018-03-19 |
| K180475 | CapLOX II® / TowerLOX® MIS Pedicle Screw System | Captiva Spine, Inc. | NKB | Class II | 2018-03-19 |
| K173930 | PYTHON Plate Trial Instruments | Treace Medical Concepts, Inc. | HRS | Class II | 2018-03-19 |
| K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | Stryker Orthopaedics | JDG | Class II | 2018-03-19 |
| K173752 | SI Screw System | Zavation Medical Products, LLC | OUR | Class II | 2018-03-16 |
| K180153 | X-spine Cortical Bone Screw System | X-Spine Systems, Inc. | NKB | Class II | 2018-03-15 |
| K180198 | NuVasive® VuePoint® II OCT System | Nu Vasive, Incorporated | NKG | Class II | 2018-03-15 |
| K173811 | TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System | In2bones Sas | HSB | Class II | 2018-03-15 |
| K171808 | TDM Plate and Screw System | Tdm Co., Ltd. | HRS | Class II | 2018-03-15 |
| K180227 | Polaris Spinal Growth System | Zimmer Biomet Spine, Inc. | PGM | Class II | 2018-03-15 |
| K173180 | Mega Plus Spine System | Bk Meditech, Co., Ltd. | NKB | Class II | 2018-03-15 |
| K173794 | AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared | Medacta International S.A. | LZO | Class II | 2018-03-14 |
| K173583 | Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners | Exactech, Inc. | OQI | Class II | 2018-03-12 |
| K173388 | Exactech Equinoxe Stemless Shoulder | Exactech, Inc. | PKC | Class II | 2018-03-09 |
| K180159 | Klassic® Knee System | Total Joint Orthopedics, Inc. | JWH | Class II | 2018-03-09 |
| K173812 | Catalyst CSR 3 Peg Glenoids | Catalyst Orthoscience, Inc. | KWT | Class II | 2018-03-09 |
| K180092 | Intellitorq | Gauthier Biomedical, Inc. | HXC | Class I | 2018-03-08 |
| K171320 | ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws | Meril Healthcare Pvt. , Ltd. | HRS | Class II | 2018-03-08 |
| K173249 | CD HORIZON Spinal System | Medtronic Sofamor Danek USA, Inc. | NKB | Class II | 2018-03-08 |
| K180156 | SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System | Globus Medical, Inc. | PEK | Class II | 2018-03-07 |
| K172267 | IRENE Thoracolumbar Fixation System | Tianjin Zhengtian Medical Instrument Co., Ltd. | NKB | Class II | 2018-03-06 |
| K173494 | OrthoSteady G Bone Cement | G21, S.R.L. | LOD | Class II | 2018-03-06 |
| K171715 | HammerTube System | Paragon 28 | HTY | Class II | 2018-03-05 |
| K173723 | EMPOWR Universal Tibial Baseplate | Encore Medical L.P. | JWH | Class II | 2018-03-05 |
| K172872 | DePuy Synthes Femoral Neck System | DePuy Synthes | KTT | Class II | 2018-03-05 |
| K173453 | Valeo® C+CSC with Lumen Interbody Fusion Device | Amedica Corp. | ODP | Class II | 2018-03-05 |
| K180334 | LEGION Knee System | Smith & Nephew, Inc. | JWH | Class II | 2018-03-05 |
| K172485 | Footmotion HammerToe | Newclip Technics | HTY | Class II | 2018-03-02 |
| K173788 | Arthrex Corkscrew FT | Arthrex, Inc. | MAI | Class II | 2018-03-01 |
| K171703 | PUMA System | Panther Orthopedics, Inc. | HTN | Class II | 2018-03-01 |
| K173746 | Activmotion Range | Newclip Technics | HRS | Class II | 2018-02-27 |
| K173324 | ALTA Anterior Cervical Interbody Spacer | Astura Medical | ODP | Class II | 2018-02-27 |
| K171797 | TRYPTIK2 C-Plate Anterior Cervical Plate System | Spineart | KWQ | Class II | 2018-02-26 |
| K172320 | Neurostructures Cavetto® Cervical Cage System | Neurostructures, Inc. | ODP | Class II | 2018-02-26 |
| K173491 | RTS Lesser MTP Implant System | In2bones USA, LLC | KWH | Class II | 2018-02-23 |
| K173077 | Cavetto-SA Cervical Cage System | Neurostructures, Inc. | OVE | Class II | 2018-02-23 |
| K180130 | ELEOS Bipolar Acetabular System | Onkos Surgical, Inc. | KWY | Class II | 2018-02-23 |
| K173693 | Orbitum Bone Staple Implant, X and VI | Orthovestments, LLC | JDR | Class II | 2018-02-23 |
| K173255 | Talon DistalFix Humeral Nail | Orthopedic Designs North America, Inc. | HSB | Class II | 2018-02-22 |
| K173334 | SeaSpine Spinous Process System | SeaSpine Orthopedics Corporation | PEK | Class II | 2018-02-22 |
| K173967 | Remedy Acetabular Cup | Osteoremedies, LLC | KWL | Class II | 2018-02-22 |
| K172294 | Osteotomy Truss System (OTS) | 4Web, Inc. | HRS | Class II | 2018-02-22 |
| K171568 | SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty | Hans Biomed Corporation | MQV | Class II | 2018-02-22 |
| K180176 | SeaSpine NewPort Spinal System | SeaSpine Orthopedics Corporation | NKB | Class II | 2018-02-20 |
| K173185 | SEURAT Universal Pedicle Screw System | Ctl Medical Corporation | NKB | Class II | 2018-02-14 |
| K173535 | Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device | Titan Spine, LLC | ODP | Class II | 2018-02-13 |
| K180118 | Arthrex NanoSuture Anchor | Arthrex, Inc. | MBI | Class II | 2018-02-12 |
| K173579 | Thorecon Fixation System | A & E Medical Corporation | JDQ | Class II | 2018-02-12 |
| K172941 | CASCADIA Interbody System | K2m | OVD | Class II | 2018-02-12 |
17,115 clearances in the Orthopedic panel. Data: openFDA.