FDA Product Code
FDA Product Code KWQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3060
510(k) Clearances — 668 records · page 2 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K200883 | CarboClear® Cervical Plate System | CarboFix Orthopedics , Ltd. | 2020-06-04 | Traditional | PDF ↗ |
| K200885 | Meridian Anterior Plate System, Regatta Lateral Plate System | SeaSpine Orthopedics Corporation | 2020-05-28 | Traditional | PDF ↗ |
| K200956 | NuVasive Thoracolumbar Plates | Nu Vasive, Incorporated | 2020-05-21 | Traditional | PDF ↗ |
| K200995 | Insignia Anterior Cervical Plate System | Alphatec Spine, Inc. | 2020-05-21 | Traditional | PDF ↗ |
| K201078 | NuVasive® ACP System | Nu Vasive, Incorporated | 2020-05-20 | Special | PDF ↗ |
| K201136 | Cure Lumbar Plate System | Meditech Spine, LLC | 2020-05-12 | Special | PDF ↗ |
| K200846 | Balteum Lumbar Plate System | Huvexel Co. , Ltd. | 2020-05-05 | Traditional | PDF ↗ |
| K200523 | Biolign® Roto-Loc Cervical Plate System | Elite Surgical Supplies (Pty), Ltd. | 2020-04-30 | Traditional | PDF ↗ |
| K193494 | Origin Anterior Cervical Plate System | Orthopaedic & Spine Development | 2020-04-06 | Traditional | PDF ↗ |
| K200224 | SEA-LINK Anterior Cervical Plate System | Indius Medical Technologies Pvt. , Ltd. | 2020-03-24 | Traditional | PDF ↗ |
| K200170 | SpineNet SSP System | Spinenet, LLC | 2020-02-05 | Traditional | PDF ↗ |
| K192792 | TranS1 AxiaLIF Plus System | Trans1 | 2019-11-20 | Traditional | PDF ↗ |
| K192049 | Oryx Cervical Plate System | Innovasis, Inc. | 2019-11-08 | Traditional | PDF ↗ |
| K192494 | NexGen Anterior Cervical Plate System | Precision Spine | 2019-10-29 | Traditional | PDF ↗ |
| K192678 | Genesys Spine Binary® Lumbar Plate System | Genesys Spine | 2019-10-24 | Special | PDF ↗ |
| K192314 | RESONATE Anterior Cervical Plate System | Globus Medical, Inc. | 2019-10-23 | Traditional | PDF ↗ |
| K191584 | FORTICO Anterior Cervical Fixation System | Camber Spine Technologies, LLC | 2019-10-22 | Traditional | PDF ↗ |
| K191500 | NuVasive® ACP System | Nu Vasive, Incorporated | 2019-09-03 | Traditional | PDF ↗ |
| K191786 | Cyclops Anterior Cervical Plate System | Degen Medical, Inc. | 2019-08-30 | Traditional | PDF ↗ |
| K192076 | Binary® Anterior Cervical Plate System | Genesys Spine | 2019-08-29 | Special | PDF ↗ |
| K190016 | Lateral Plate System | Corelink, LLC | 2019-06-12 | Traditional | PDF ↗ |
| K190565 | Cervical Plate | Eisertech, LLC | 2019-05-31 | Traditional | PDF ↗ |
| K183084 | Fuji Cervical Plate System | Altus Partners, LLC | 2019-05-29 | Special | PDF ↗ |
| K190584 | CAYMAN LP Plate System | K2m, Inc. | 2019-05-15 | Traditional | PDF ↗ |
| K190170 | MVP Cervical Plate System | GS Medical Co., Ltd. | 2019-05-13 | Traditional | PDF ↗ |
| K190666 | CYGNUS Anterior Cervical Plate System | MiRus, LLC | 2019-05-09 | Traditional | PDF ↗ |
| K190227 | Boomerang Anterior Cervical Plate System | Choicespine, LP | 2019-05-01 | Traditional | PDF ↗ |
| K183056 | ASSURE® Anterior Cervical Plate System | Globus Medical, Inc. | 2019-04-19 | Traditional | PDF ↗ |
| K190425 | CastleLoc-P Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | 2019-03-21 | Special | PDF ↗ |
| K183409 | Athena II Cervical Plate System | Medyssey USA, Inc. | 2019-02-11 | Traditional | PDF ↗ |
| K183073 | SMG Anterior Cervical Plate System | Sapphire Medical Group | 2019-02-11 | Traditional | PDF ↗ |
| K182885 | Atlantis Anterior Cervical Plate, Divergence Anterior Cervical Fusion System, Premier Anterior Cervical Plate, Venture Anterior Cervical Plate, Zephir Anterior Cervical Plate System and Zevo Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. | 2019-02-06 | Traditional | PDF ↗ |
| K190053 | SECULOK ACP System | U&I Corporation | 2019-02-01 | Special | PDF ↗ |
| K183060 | CervAlign Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2019-01-17 | Traditional | PDF ↗ |
| K181190 | Pinehurst Anterior Cervical Plate System | Signature Orthopaedics Pty, Ltd. | 2019-01-17 | Traditional | PDF ↗ |
| K182489 | 4CIS® Pinehurst Anterior Cervical Plate system | Solco Biomedical Co., Ltd. | 2019-01-16 | Traditional | PDF ↗ |
| K183214 | Raven Lumbar Plate System | Choicespine, LP | 2019-01-03 | Traditional | PDF ↗ |
| K180772 | Met One Czar Anterior Cervical Plate System | Met One Technologies | 2018-12-17 | Traditional | PDF ↗ |
| K182473 | PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems | K2m, Inc. | 2018-12-12 | Traditional | PDF ↗ |
| K182418 | V3 Segmental Plating System | Atlas Spine, Inc. | 2018-11-29 | Traditional | PDF ↗ |
| K182808 | Aspida® Anterior Lumbar Plating System | Alphatec Spine, Inc. | 2018-11-09 | Traditional | PDF ↗ |
| K181846 | ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty Fixation System | Globus Medical, Inc. | 2018-11-06 | Traditional | PDF ↗ |
| K182055 | SECULOK ACP System | U&I Corporation | 2018-09-10 | Traditional | PDF ↗ |
| K181543 | Cure OPEL-C Plate System | Meditech Spine, LLC | 2018-08-31 | Traditional | PDF ↗ |
| K181549 | Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) | Curiteva, LLC | 2018-08-03 | Traditional | PDF ↗ |
| K181562 | Curiteva Anterior Cervical Plate System | Curiteva, LLC | 2018-08-02 | Traditional | PDF ↗ |
| K180022 | Athena Cervical Plate System | Medyssey USA, Inc. | 2018-07-20 | Traditional | PDF ↗ |
| K181063 | Kestrel Buttress Plate System | Innovasis, Inc. | 2018-07-13 | Traditional | PDF ↗ |
| K181244 | Zavation Cervical Plate System | Zavation Medical Products, LLC | 2018-07-10 | Traditional | PDF ↗ |
| K180755 | Vail ALIF Buttress Plate System | Evolution Spine, LLC | 2018-07-06 | Traditional | PDF ↗ |
| K180166 | Life Spine Lumbar Fixation System (SENTRY) | Life Spine, Inc. | 2018-06-22 | Traditional | PDF ↗ |
| K180090 | Cure Lumbar Plate System | Meditech Spine, LLC | 2018-04-23 | Special | PDF ↗ |
| K173935 | Mediant Anterior Cervical Plating System | Intelligent Implant Systems, LLC | 2018-04-16 | Traditional | PDF ↗ |
| K173867 | Axis Anterior Cervical Plate System | Axis Orthopaedics | 2018-04-05 | Traditional | PDF ↗ |
| K173885 | Genesys Spine Binary Lumbar Plate System | Genesys Spine | 2018-04-03 | Traditional | PDF ↗ |
| K180537 | Zavation Buttress Plate System | Zavation Medical Products, LLC | 2018-03-27 | Traditional | PDF ↗ |
| K171797 | TRYPTIK2 C-Plate Anterior Cervical Plate System | Spineart | 2018-02-26 | Traditional | PDF ↗ |
| K173521 | SeaSpine Cabo ACP (Anterior Cervical Plate) System | SeaSpine Orthopedics Corporation | 2018-01-24 | Traditional | PDF ↗ |
| K173306 | EZ Plate | Zavation Medical Products, LLC | 2018-01-22 | Traditional | PDF ↗ |
| K173375 | Anterior Cervical Plate System | Evolution Spine, LLC | 2017-12-21 | Traditional | PDF ↗ |
| K173091 | Boundary Anterior Lumbar Buttress Plate | Nvision Biomedical Technologies, LLC | 2017-12-06 | Traditional | PDF ↗ |
| K173099 | Fortis and Hana Anterior Cervical Plate System | Huvexel Co. , Ltd. | 2017-11-30 | Traditional | PDF ↗ |
| K172585 | Liberty Anterior Cervical Plate | Valorus Spine | 2017-10-23 | Traditional | PDF ↗ |
| K163366 | Shanghai Sanyou CARMEN Cervical Fusion System | Shanghai Sanyou Medical Co, Ltd. | 2017-10-05 | Traditional | PDF ↗ |
| K172086 | Matira Anterior Cervical System | Kalitec Direct, LLC | 2017-09-22 | Traditional | PDF ↗ |
| K172131 | 2 Hole Lateral Plating System | Life Spine, Inc. | 2017-08-28 | Traditional | PDF ↗ |
| K172104 | Ozark(tm) Cervical Plate System | K2m, Inc. | 2017-08-23 | Traditional | PDF ↗ |
| K163625 | NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System | Signature Orthopaedics Pty, Ltd. | 2017-08-11 | Traditional | PDF ↗ |
| K171439 | EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System | Medos International SARL | 2017-07-20 | Traditional | PDF ↗ |
| K170224 | Spider Cervical Plating System | X-Spine Systems, Inc. | 2017-07-06 | Traditional | PDF ↗ |
| K163104 | Terrace Anterior Cervical Plate System | Corelink, LLC | 2017-06-21 | Traditional | PDF ↗ |
| K171538 | Cure Lumbar Plate System | Meditech Spine, LLC | 2017-06-16 | Traditional | PDF ↗ |
| K171112 | Trifore(tm) Cervical Plating System | Neurostructures, Inc. | 2017-06-08 | Traditional | PDF ↗ |
| K170342 | Ocata Anterior Cervical System | Kalitec Direct, LLC | 2017-05-09 | Traditional | PDF ↗ |
| K170530 | Butrex Lumbar Buttress Plating System | X-Spine Systems, Inc. | 2017-03-22 | Special | PDF ↗ |
| K162824 | Z-Span Plate System | Zavation, LLC | 2017-02-17 | Traditional | PDF ↗ |
| K163602 | Kepler I Cervical Plate System | Orbbo Surgical, LLC | 2017-02-16 | Traditional | PDF ↗ |
| K163061 | Altus Spine Cervical Plate System | Altus Partners, LLC | 2017-02-06 | Traditional | PDF ↗ |
| K161641 | LOSPA IS ACP System | Corentec Co., Ltd. | 2017-01-05 | Traditional | PDF ↗ |
| K160982 | Sphynx | Eden Spine, LLC | 2016-12-22 | Traditional | PDF ↗ |
| K162638 | CETRA Anterior Cervical Plate System | Orthofix, Inc. | 2016-12-16 | Traditional | PDF ↗ |
| K162194 | MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System | Medicrea International SA | 2016-12-08 | Traditional | PDF ↗ |
| K162211 | AccuFit Lateral Plate System | Precision Spine, Inc. | 2016-11-28 | Traditional | PDF ↗ |
| K162250 | FortiBridge Anterior Cervical Plate System | Nanovis Spine, LLC | 2016-10-26 | Special | PDF ↗ |
| K162664 | Pyrenees Cervical Plate System | K2m, Inc. | 2016-10-07 | Special | PDF ↗ |
| K161524 | Tangis Anterior Cervical Plate | Nvision Biomedical Technologies, LLC | 2016-09-02 | Traditional | PDF ↗ |
| K160702 | ZION Anterior Cervical Fixation System | Astura Medical | 2016-08-23 | Traditional | PDF ↗ |
| K153097 | Belvedere Lateral Plating System | Neurostructures, Inc. | 2016-07-15 | Traditional | PDF ↗ |
| K160604 | Cure Anterior Cervical Plate (ACP) System | Meditech Spine, LLC | 2016-07-01 | Traditional | PDF ↗ |
| K153526 | Pyrenees Cervical Plate System | K2m | 2016-04-27 | Traditional | PDF ↗ |
| K160522 | White Pearl Preferred Angle Anterior Cervical Plate | Osseus Fusion Systems, LLC | 2016-04-26 | Traditional | PDF ↗ |
| K153042 | TRYPTIK2C-plate Anterior Cervical Plate System | Spineart | 2016-03-28 | Traditional | PDF ↗ |
| K160362 | Z-Span Plate System | Zavation, LLC | 2016-03-22 | Traditional | PDF ↗ |
| K151553 | Anterior Cervical Plate System | Osteomed Implantes, Ltda | 2016-02-10 | Traditional | PDF ↗ |
| K152239 | Zero-P Natural Plate System | Synthes (Usa), LLC | 2015-12-02 | Traditional | PDF ↗ |
| K152282 | Cam Lock Plating System | Life Spine, Inc. | 2015-11-20 | Traditional | PDF ↗ |
| K152623 | ATLANTIS Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. | 2015-11-12 | Traditional | PDF ↗ |
| K152455 | Amendia Cervical Plate System | Amendia, Inc. | 2015-10-15 | Traditional | PDF ↗ |
| K152193 | Renovis Anterior Cervical Plate System | Renovis Surgical Technologies, Inc. | 2015-09-25 | Traditional | PDF ↗ |
| K152281 | Pyrenees Cervical Plate System | K2m | 2015-09-24 | Special | PDF ↗ |
Product code KWQ · Class II · Orthopedic. Data: openFDA.