KWQ · Appliance, Fixation, Spinal Intervertebral Body
Orthopedic · 21 CFR 888.3060 · Class 2
Overview
| Product Code | KWQ |
|---|---|
| Device Name | Appliance, Fixation, Spinal Intervertebral Body |
| Regulation | 21 CFR 888.3060 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.
Classification Rationale
Class II.
Cleared Devices (663)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260697 | VyPlate Anterior Cervical Plate System | Vy Spine, LLC | Mar 27, 2026 | SESE |
| K260015 | ANTERIS Thoracolumbar Plate System | SpineCraft | Mar 4, 2026 | SESE |
| K251940 | PathLoc Lumbar Plate System | L&K BIOMED Co., Ltd. | Mar 3, 2026 | SESE |
| K254182 | Aster | Osteonic Co., Ltd. | Feb 26, 2026 | SESE |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS) | 4Web, Inc. | Feb 12, 2026 | SESE |
| K252611 | aprevo® cervical plating system | Carlsmed, Inc. | Dec 22, 2025 | SESE |
| K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) | Alphatec Spine, Inc. | Aug 28, 2025 | SESE |
| K251436 | Resolve Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | Jul 11, 2025 | SESE |
| K250446 | Frida Anterior Cervical Plate System | Spineup, Inc. | May 23, 2025 | SESE |
| K250602 | X-PAC® N-GAGE Lumbar Plate System | Expanding Innovations, Inc. | May 20, 2025 | SESE |
| K250486 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | Apr 10, 2025 | SESE |
| K243904 | Elegance® Anterior Cervical plate | Clariance | Jan 14, 2025 | SESE |
| K243369 | Cervical Plating System | Life Spine, Inc. | Dec 11, 2024 | SESE |
| K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI | Stryker Spine | Nov 7, 2024 | SESE |
| K243015 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies, Inc. | Nov 5, 2024 | SESE |
| K231251 | FlexWing Anterior Cervical Plate System | Jeil Medical Corporation | Jul 24, 2024 | SESE |
| K240592 | Wolff's Law Anterior Cervical Plate System | Spinal Simplicity, LLC | May 24, 2024 | SESE |
| K241175 | MiRus MoRe Lumbar Plating System | MiRus, LLC | May 17, 2024 | SESE |
| K240935 | ARENAL Anterior Cervical Plate System | Effortmed, LLC | May 17, 2024 | SESE |
| K233215 | icotec Anterior Cervical Plate System | Icotec AG | May 17, 2024 | SESE |
| K240484 | MSFX Mikron Cervical Anterior Plate System | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | Apr 17, 2024 | SESE |
| K232256 | Alcantara Thoracolumbar Plate System | Camber Spine Technologies, LLC | Apr 16, 2024 | SESE |
| K240423 | TDM Anterior Cervical Plate System | Tdm Co., Ltd. | Apr 8, 2024 | SESE |
| K240690 | STRUXXURE® MCS Anterior Cervical Plate System | Nexxt Spine | Mar 22, 2024 | SESE |
| K240515 | uNion® MAX Cervical Plate System | Ulrich Medical USA, Inc. | Mar 18, 2024 | SESE |
| K233360 | Curiteva Thoracolumbar Plate System | Curiteva, Inc. | Feb 29, 2024 | SESE |
| K233640 | Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System | Alphatec Spine, Inc. | Feb 22, 2024 | SESE |
| K231715 | MONDRIAN Anterior Lumbar Plate System | Ctl Medical Corporation | Jan 26, 2024 | SESE |
| K233735 | ADIRA Lateral Plate System | Globus Medical, Inc. | Jan 25, 2024 | SESE |
| K232318 | VICTORY Lumbar Plate System | Globus Medical, Inc. | Oct 31, 2023 | SESE |
| K231766 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | Sep 12, 2023 | SESE |
| K231593 | Sapphire X3 Anterior Cervical Plate System | Spinal Elements, Inc. | Aug 2, 2023 | SESE |
| K231839 | CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System | L&K BIOMED Co., Ltd. | Jul 19, 2023 | SESE |
| K231460 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM & BALTEUM-ONE Lumbar Plate System, and Osprey Anterior Cervical Plate System | K&J Consulting Corp. | Jul 16, 2023 | SESE |
| K230993 | CODA Anterior Cervical Plate System | Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech | Jun 20, 2023 | SESE |
| K231090 | Zevo Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. | Jun 15, 2023 | SESE |
| K231145 | Axis Anterior Cervical Plate System | Southern Medical (Pty) , Ltd. | Jun 13, 2023 | SESE |
| K230721 | ATEC Lateral Plate System | Alphatec Spine, Inc. | May 9, 2023 | SESE |
| K230424 | Omnia Medical Coupler-A Anterior Lumbar Plate System; Omnia Medical Coupler-L Lateral Lumbar Plate System | Omnia Medical, LLC | Apr 12, 2023 | SESE |
| K223753 | Cervical Plate System | Double Medical Technology, Inc. | Mar 14, 2023 | SESE |
| K223321 | Omnia Medical Coupler-C Anterior Cervical Plate | Omnia Medical, LLC | Mar 13, 2023 | SESE |
| K230301 | Athena III Cervical Plate System | Medyssey USA, Inc. | Mar 7, 2023 | SESE |
| K221053 | Magnes-C Anterior Cervical Plate System | Fellowship of Orthopaedic Researchers, Inc. | Mar 1, 2023 | SESE |
| K223627 | PreView-III Anterior Cervical Plate System | Nexus Spine, LLC | Feb 2, 2023 | SESE |
| K223719 | Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System | Aegis Spine, Inc. | Jan 11, 2023 | SESE |
| K220843 | OAKTREE Anterior Lumbar Plate and Screw System | Oak Tree Engineering, LLC | Dec 7, 2022 | SESE |
| K222493 | CODA Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | Nov 18, 2022 | SESE |
| K222628 | Life Spine ALIF Buttress Plate System | Life Spine, Inc. | Nov 16, 2022 | SESE |
| K220334 | MONET Anterior Cervical Plate System | Ctl Medical Corporation | Nov 9, 2022 | SESE |
| K221728 | Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran Anterior Cervical Plating (ACP) System, Reflex Hybrid ACP System, UniVise Spinous Process Fixation Plate | Stryker Corporation | Oct 19, 2022 | SESE |
| K222572 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM & BALTEUM-ONE Lumbar Plate System | Dio Medical Corporation | Oct 18, 2022 | SESE |
| K220441 | CYGNUS MoRe Anterior Cervical Plate System | MiRus, LLC | Sep 16, 2022 | SESE |
| K221572 | VyPlate Anterior Cervical Plate System | Vy Spine, LLC | Jul 26, 2022 | SESE |
| K211718 | Venus Cervical Plate System | Artfx Medical, LLC | Jun 28, 2022 | SESE |
| K212527 | Cervical Spine Truss System Plating Solution (CSTS-PS) | 4Web Medical, Inc. | May 17, 2022 | SESE |
| K220182 | Aggeris-C | Clariance | Mar 30, 2022 | SESE |
| K213820 | BALTEUM - ONE Lumbar Plate System | Huvexel Co. , Ltd. | Mar 25, 2022 | SESE |
| K220275 | EMERGE Anterior Cervical Plate System | Evolution Spine | Mar 18, 2022 | SESE |
| K220324 | AccuFit Lateral 2-Hole Plate | Precision Spine, Inc. | Mar 16, 2022 | SESE |
| K220379 | IMPEACE and IMPEACE-Uni Anterior Cervical Plate System | Medynus, Inc. | Mar 3, 2022 | SESE |
| K220147 | Aspiron S ACP System | U&I Corporation | Feb 16, 2022 | SESE |
| K211712 | 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System | Orthofix US, LLC | Feb 11, 2022 | SESE |
| K213901 | Cyclops Anterior Cervical Plate System | Degen Medical | Jan 7, 2022 | SESE |
| K213219 | Vy Spine VyWasher Buttress System | Vy Spine, LLC | Dec 23, 2021 | SESE |
| K213456 | Xenco Medical Multilevel CerviKit | Xenco Medical, LLC | Dec 21, 2021 | SESE |
| K213443 | Insignia Anterior Cervical Plate System | Alphatec Spine, Inc. | Dec 15, 2021 | SESE |
| K212937 | Dakota ALIF Plate System | Precision Spine, Inc. | Nov 4, 2021 | SESE |
| K212446 | NuVasive Anterior Cervical Plate Systems | Nu Vasive, Incorporated | Nov 3, 2021 | SESE |
| K210424 | Quantum Anterior Cervical Plate | Nvision Biomedical Technologies, Inc. | Oct 22, 2021 | SESE |
| K212405 | EMERGE Anterior Cervical Plate System | Evolution Spine | Sep 30, 2021 | SESE |
| K212139 | Admiral ACP System | SeaSpine Orthopedics Corporation | Sep 1, 2021 | SESE |
| K211903 | Shoreline Threaded TruProfile® Plate | SeaSpine Orthopedics Corporation | Aug 30, 2021 | SESE |
| K211205 | Prase-C Anterior Cervical Plate System | Gbs Commonwealth Co., Ltd. | Aug 12, 2021 | SESE |
| K211932 | Fixxsure Anterior Lumbar Plate and Screw System | Oak Tree Engineering, LLC | Jul 27, 2021 | SESE |
| K211408 | CervAlign® Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | Jun 23, 2021 | SESE |
| K210182 | PANAMA Anterior Cervical Plate (ACP) System | Flospine | Apr 7, 2021 | SESE |
| K210325 | APOLLO Anterior Cervical Plate (ACP) System | Aurora Spine, Inc. | Mar 23, 2021 | SESE |
| K210286 | Cure 2.0 Anterior Cervical Plate (ACP) System | Meditech Spine, LLC | Mar 18, 2021 | SESE |
| K203065 | Lumbar Spine Truss System Plating Solution (LSTS-PS) | 4Web, Inc. | Mar 10, 2021 | SESE |
| K202878 | Prase-AP Anterior Cervical Plate System | Gbs Commonwealth Co., Ltd. | Jan 29, 2021 | SESE |
| K203253 | NuVasive ACP System | Nu Vasive, Incorporated | Dec 3, 2020 | SESE |
| K202972 | Anterior Cervical Plate System | Nutech Spine and Biologics | Nov 24, 2020 | SESE |
| K203154 | KASILOF Cervical Plate System | Kahtnu Surgical, Inc. | Nov 5, 2020 | SESE |
| K202624 | Z-Span Plate System | Zavation Medical Products, LLC | Nov 4, 2020 | SESE |
| K201587 | icotec Anterior Cervical Plate System | Icotec AG | Oct 15, 2020 | SESE |
| K202309 | Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System | Zimmer Biomet Spine, Inc. | Oct 8, 2020 | SESE |
| K202192 | STRUXXURE®-L and STRUXXURE®-A Plate System | Nexxt Spine, LLC | Sep 17, 2020 | SESE |
| K202227 | Artus cervical plate system | Ulrich GmbH & Co. KG | Sep 14, 2020 | SESE |
| K202064 | Admiral ACP System | SeaSpine Orthopedics Corporation | Aug 26, 2020 | SESE |
| K201979 | Cervical Plate System | Eminent Spine, LLC | Aug 25, 2020 | SESE |
| K201521 | Medina Anterior Cervical Plate System | Alliance Partners, LLC | Aug 6, 2020 | SESE |
| K201079 | Aurora® Anterior Lumbar Plate Sytstem | Prism Surgical Design Pty , Ltd. | Aug 5, 2020 | SESE |
| K192481 | AccelFix Lumbar Plate System | L&K BIOMED Co., Ltd. | Jul 28, 2020 | SESE |
| K200927 | Transept Cervical Plate System | Neurostructures, Inc. | Jul 24, 2020 | SESE |
| K201029 | Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System | Spinal Elements, Inc. | Jun 17, 2020 | SESE |
| K200883 | CarboClear® Cervical Plate System | CarboFix Orthopedics , Ltd. | Jun 4, 2020 | SESE |
| K200885 | Meridian Anterior Plate System, Regatta Lateral Plate System | SeaSpine Orthopedics Corporation | May 28, 2020 | SESE |
| K200995 | Insignia Anterior Cervical Plate System | Alphatec Spine, Inc. | May 21, 2020 | SESE |
| K200956 | NuVasive Thoracolumbar Plates | Nu Vasive, Incorporated | May 21, 2020 | SESE |
| K201078 | NuVasive® ACP System | Nu Vasive, Incorporated | May 20, 2020 | SESE |
| K201136 | Cure Lumbar Plate System | Meditech Spine, LLC | May 12, 2020 | SESE |
| K200846 | Balteum Lumbar Plate System | Huvexel Co. , Ltd. | May 5, 2020 | SESE |
| K200523 | Biolign® Roto-Loc Cervical Plate System | Elite Surgical Supplies (Pty), Ltd. | Apr 30, 2020 | SESE |
| K193494 | Origin Anterior Cervical Plate System | Orthopaedic & Spine Development | Apr 6, 2020 | SESE |
| K200224 | SEA-LINK Anterior Cervical Plate System | Indius Medical Technologies Pvt. , Ltd. | Mar 24, 2020 | SESE |
| K200170 | SpineNet SSP System | Spinenet, LLC | Feb 5, 2020 | SESE |
| K192792 | TranS1 AxiaLIF Plus System | Trans1 | Nov 20, 2019 | SESE |
| K192049 | Oryx Cervical Plate System | Innovasis, Inc. | Nov 8, 2019 | SESE |
| K192494 | NexGen Anterior Cervical Plate System | Precision Spine | Oct 29, 2019 | SESE |
| K192678 | Genesys Spine Binary® Lumbar Plate System | Genesys Spine | Oct 24, 2019 | SESE |
| K192314 | RESONATE Anterior Cervical Plate System | Globus Medical, Inc. | Oct 23, 2019 | SESE |
| K191584 | FORTICO Anterior Cervical Fixation System | Camber Spine Technologies, LLC | Oct 22, 2019 | SESE |
| K191500 | NuVasive® ACP System | Nu Vasive, Incorporated | Sep 3, 2019 | SESE |
| K191786 | Cyclops Anterior Cervical Plate System | Degen Medical, Inc. | Aug 30, 2019 | SESE |
| K192076 | Binary® Anterior Cervical Plate System | Genesys Spine | Aug 29, 2019 | SESE |
| K190016 | Lateral Plate System | Corelink, LLC | Jun 12, 2019 | SESE |
| K190565 | Cervical Plate | Eisertech, LLC | May 31, 2019 | SESE |
| K183084 | Fuji Cervical Plate System | Altus Partners, LLC | May 29, 2019 | SESE |
| K190584 | CAYMAN LP Plate System | K2m, Inc. | May 15, 2019 | SESE |
| K190170 | MVP Cervical Plate System | GS Medical Co., Ltd. | May 13, 2019 | SESE |
| K190666 | CYGNUS Anterior Cervical Plate System | MiRus, LLC | May 9, 2019 | SESE |
| K190227 | Boomerang Anterior Cervical Plate System | Choicespine, LP | May 1, 2019 | SESE |
| K183056 | ASSURE® Anterior Cervical Plate System | Globus Medical, Inc. | Apr 19, 2019 | SESE |
| K190425 | CastleLoc-P Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | Mar 21, 2019 | SESE |
| K183409 | Athena II Cervical Plate System | Medyssey USA, Inc. | Feb 11, 2019 | SESE |
| K183073 | SMG Anterior Cervical Plate System | Sapphire Medical Group | Feb 11, 2019 | SESE |
| 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. | Feb 6, 2019 | SESE |
| K190053 | SECULOK ACP System | U&I Corporation | Feb 1, 2019 | SESE |
| K183060 | CervAlign Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | Jan 17, 2019 | SESE |
| K181190 | Pinehurst Anterior Cervical Plate System | Signature Orthopaedics Pty, Ltd. | Jan 17, 2019 | SESE |
| K182489 | 4CIS® Pinehurst Anterior Cervical Plate system | Solco Biomedical Co., Ltd. | Jan 16, 2019 | SESE |
| K183214 | Raven Lumbar Plate System | Choicespine, LP | Jan 3, 2019 | SESE |
| K180772 | Met One Czar Anterior Cervical Plate System | Met One Technologies | Dec 17, 2018 | SESE |
| K182473 | PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems | K2m, Inc. | Dec 12, 2018 | SESE |
| K182418 | V3 Segmental Plating System | Atlas Spine, Inc. | Nov 29, 2018 | SESE |
| K182808 | Aspida® Anterior Lumbar Plating System | Alphatec Spine, Inc. | Nov 9, 2018 | SESE |
| 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. | Nov 6, 2018 | SESE |
| K182055 | SECULOK ACP System | U&I Corporation | Sep 10, 2018 | SESE |
| K181543 | Cure OPEL-C Plate System | Meditech Spine, LLC | Aug 31, 2018 | SESE |
| K181549 | Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) | Curiteva, LLC | Aug 3, 2018 | SESE |
| K181562 | Curiteva Anterior Cervical Plate System | Curiteva, LLC | Aug 2, 2018 | SESE |
| K180022 | Athena Cervical Plate System | Medyssey USA, Inc. | Jul 20, 2018 | SESE |
| K181063 | Kestrel Buttress Plate System | Innovasis, Inc. | Jul 13, 2018 | SESE |
| K181244 | Zavation Cervical Plate System | Zavation Medical Products, LLC | Jul 10, 2018 | SESE |
| K180755 | Vail ALIF Buttress Plate System | Evolution Spine, LLC | Jul 6, 2018 | SESE |
| K180166 | Life Spine Lumbar Fixation System (SENTRY) | Life Spine, Inc. | Jun 22, 2018 | SESE |
| K180090 | Cure Lumbar Plate System | Meditech Spine, LLC | Apr 23, 2018 | SESE |
| K173935 | Mediant Anterior Cervical Plating System | Intelligent Implant Systems, LLC | Apr 16, 2018 | SESE |
| K173867 | Axis Anterior Cervical Plate System | Axis Orthopaedics | Apr 5, 2018 | SESE |
| K173885 | Genesys Spine Binary Lumbar Plate System | Genesys Spine | Apr 3, 2018 | SESE |
| K180537 | Zavation Buttress Plate System | Zavation Medical Products, LLC | Mar 27, 2018 | SESE |
| K171797 | TRYPTIK2 C-Plate Anterior Cervical Plate System | Spineart | Feb 26, 2018 | SESE |
| K173521 | SeaSpine Cabo ACP (Anterior Cervical Plate) System | SeaSpine Orthopedics Corporation | Jan 24, 2018 | SESE |
| K173306 | EZ Plate | Zavation Medical Products, LLC | Jan 22, 2018 | SESE |
| K173375 | Anterior Cervical Plate System | Evolution Spine, LLC | Dec 21, 2017 | SESE |
| K173091 | Boundary Anterior Lumbar Buttress Plate | Nvision Biomedical Technologies, LLC | Dec 6, 2017 | SESE |
| K173099 | Fortis and Hana Anterior Cervical Plate System | Huvexel Co. , Ltd. | Nov 30, 2017 | SESE |
| K172585 | Liberty Anterior Cervical Plate | Valorus Spine | Oct 23, 2017 | SESE |
| K163366 | Shanghai Sanyou CARMEN Cervical Fusion System | Shanghai Sanyou Medical Co, Ltd. | Oct 5, 2017 | SESE |
| K172086 | Matira Anterior Cervical System | Kalitec Direct, LLC | Sep 22, 2017 | SESE |
| K172131 | 2 Hole Lateral Plating System | Life Spine, Inc. | Aug 28, 2017 | SESE |
| K172104 | Ozark(tm) Cervical Plate System | K2m, Inc. | Aug 23, 2017 | SESE |
| K163625 | NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System | Signature Orthopaedics Pty, Ltd. | Aug 11, 2017 | SESE |
| 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 | Jul 20, 2017 | SESE |
| K170224 | Spider Cervical Plating System | X-Spine Systems, Inc. | Jul 6, 2017 | SESE |
| K163104 | Terrace Anterior Cervical Plate System | Corelink, LLC | Jun 21, 2017 | SESE |
| K171538 | Cure Lumbar Plate System | Meditech Spine, LLC | Jun 16, 2017 | SESE |
| K171112 | Trifore(tm) Cervical Plating System | Neurostructures, Inc. | Jun 8, 2017 | SESE |
| K170342 | Ocata Anterior Cervical System | Kalitec Direct, LLC | May 9, 2017 | SESE |
| K170530 | Butrex Lumbar Buttress Plating System | X-Spine Systems, Inc. | Mar 22, 2017 | SESE |
| K162824 | Z-Span Plate System | Zavation, LLC | Feb 17, 2017 | SESE |
| K163602 | Kepler I Cervical Plate System | Orbbo Surgical, LLC | Feb 16, 2017 | SESE |
| K163061 | Altus Spine Cervical Plate System | Altus Partners, LLC | Feb 6, 2017 | SESE |
| K161641 | LOSPA IS ACP System | Corentec Co., Ltd. | Jan 5, 2017 | SESE |
| K160982 | Sphynx | Eden Spine, LLC | Dec 22, 2016 | SESE |
| K162638 | CETRA Anterior Cervical Plate System | Orthofix, Inc. | Dec 16, 2016 | SESE |
| K162194 | MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System | Medicrea International SA | Dec 8, 2016 | SESE |
| K162211 | AccuFit Lateral Plate System | Precision Spine, Inc. | Nov 28, 2016 | SESE |
| K162250 | FortiBridge Anterior Cervical Plate System | Nanovis Spine, LLC | Oct 26, 2016 | SESE |
| K162664 | Pyrenees Cervical Plate System | K2m, Inc. | Oct 7, 2016 | SESE |
| K161524 | Tangis Anterior Cervical Plate | Nvision Biomedical Technologies, LLC | Sep 2, 2016 | SESE |
| K160702 | ZION Anterior Cervical Fixation System | Astura Medical | Aug 23, 2016 | SESE |
| K153097 | Belvedere Lateral Plating System | Neurostructures, Inc. | Jul 15, 2016 | SESE |
| K160604 | Cure Anterior Cervical Plate (ACP) System | Meditech Spine, LLC | Jul 1, 2016 | SESE |
| K153526 | Pyrenees Cervical Plate System | K2m | Apr 27, 2016 | SESE |
| K160522 | White Pearl Preferred Angle Anterior Cervical Plate | Osseus Fusion Systems, LLC | Apr 26, 2016 | SESE |
| K153042 | TRYPTIK2C-plate Anterior Cervical Plate System | Spineart | Mar 28, 2016 | SESE |
| K160362 | Z-Span Plate System | Zavation, LLC | Mar 22, 2016 | SESE |
| K151553 | Anterior Cervical Plate System | Osteomed Implantes, Ltda | Feb 10, 2016 | SESE |
| K152239 | Zero-P Natural Plate System | Synthes (Usa), LLC | Dec 2, 2015 | SESE |
| K152282 | Cam Lock Plating System | Life Spine, Inc. | Nov 20, 2015 | SESE |
| K152623 | ATLANTIS Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. | Nov 12, 2015 | SESE |
| K152455 | Amendia Cervical Plate System | Amendia, Inc. | Oct 15, 2015 | SESE |
| K152193 | Renovis Anterior Cervical Plate System | Renovis Surgical Technologies, Inc. | Sep 25, 2015 | SESE |
| K152281 | Pyrenees Cervical Plate System | K2m | Sep 24, 2015 | SESE |
| K152015 | Pyrenees Cervical Plate System | K2m, Inc. | Sep 4, 2015 | SESE |
| K150759 | Hyper-C Anterior Cervical Plate System | Degen Medical | Jul 28, 2015 | SESE |
| K150700 | ACP 1 Anterior Cervical Plating System | Stryker Corporation | Jul 15, 2015 | SESE |
| K150983 | Pyrenees Cervical Plate System | K2m | Jul 14, 2015 | SESE |
| K150834 | Atrax Anterior Cervical Plating System | X-Spine Systems, Inc. | Jul 10, 2015 | SESE |
Top Applicants
- Nuvasive, Inc. — 21 clearances
- K2m, Inc. — 15 clearances
- Globus Medical, Inc. — 15 clearances
- Medtronic Sofamor Danek — 13 clearances
- Blackstone Medical, Inc. — 13 clearances
