ClearanceBrief
Panels › Orthopedic › Product code KWQ · Class 2

Appliance, Fixation, Spinal Intervertebral Body

Regulation 888.3060

11510(k)s in 12 months (668 all time)
1recalls in 12 months (214 all time)
165recalls that name a 510(k)
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Top companies in KWQ

Company510(k)sRecalls
Stryker Spine638
Alphatec Spine, Inc.932
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)041
Zimmer, Inc.137
Medtronic Sofamor Danek298
Nuvasive, Inc.210
K2m200
Depuy Spine, Inc.108
Blackstone Medical, Inc.133
Globus Medical, Inc.150
Decided510(k)Device and applicantCode
Sep 24, 2026K262149corra® cervical plating system
Carlsmed, Inc.
KWQ
Jul 16, 2026K261309Palisades™ Buttress Plate System
Bethesda Medical Devices, LLC
KWQ
May 14, 2026K252776ARIES Anterior Cervical Plate Systems
ZheJiang Decans Medical Devices Co., Ltd., CN
KWQ
May 6, 2026K261112CastleLoc-P Anterior Cervical Plate System
L&K BIOMED Co., Ltd., KR
KWQ
Apr 22, 2026K260570corra™ cervical plating system
Carlsmed, Inc.
KWQ
Mar 27, 2026K260697VyPlate™ Anterior Cervical Plate System
Vy Spine, LLC
KWQ
Mar 4, 2026K260015ANTERIS Thoracolumbar Plate System
SpineCraft
KWQ
Mar 3, 2026K251940PathLoc Lumbar Plate System
L&K BIOMED Co., Ltd., KR
KWQ
Feb 26, 2026K254182Aster
Osteonic Co., Ltd., KR
KWQ
Feb 12, 2026K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)
4Web, Inc.
KWQ
Dec 22, 2025K252611aprevo® cervical plating system
Carlsmed, Inc.
KWQ
Aug 28, 2025K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)
Alphatec Spine, Inc.
KWQ
Jul 11, 2025K251436Resolve Anterior Cervical Plate System
Pioneer Surgical Technology, Inc.
KWQ
May 23, 2025K250446Frida™ Anterior Cervical Plate System
Spineup, Inc.
KWQ
May 20, 2025K250602X-PAC® N-GAGE™ Lumbar Plate System
Expanding Innovations, Inc.
KWQ
Apr 10, 2025K250486Skyway Anterior Cervical Plate System
Kyocera Medical Technologies Inc. (KMTI)
KWQ
Jan 14, 2025K243904Elegance® Anterior Cervical plate
Clariance, FR
KWQ
Dec 11, 2024K243369Cervical Plating System
Life Spine, Inc.
KWQ
Nov 7, 2024K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small S
Stryker Spine
KWQ
Nov 5, 2024K243015Skyway Anterior Cervical Plate System
Kyocera Medical Technologies, Inc.
KWQ
Jul 24, 2024K231251FlexWing Anterior Cervical Plate System
Jeil Medical Corporation, KR
KWQ
May 24, 2024K240592Wolff's Law Anterior Cervical Plate System
Spinal Simplicity, LLC
KWQ
May 17, 2024K241175MiRus MoRe Lumbar Plating System
MiRus, LLC
KWQ
May 17, 2024K240935ARENAL Anterior Cervical Plate System
Effortmed, LLC
KWQ
May 17, 2024K233215icotec Anterior Cervical Plate System
Icotec AG, CH
KWQ
Apr 17, 2024K240484MSFX Mikron Cervical Anterior Plate System
Mikron Makina Sanayi VE Ticaret Ltd. Sti., TR
KWQ
Apr 16, 2024K232256Alcantara Thoracolumbar Plate System
Camber Spine Technologies, LLC
KWQ
Apr 8, 2024K240423TDM Anterior Cervical Plate System
Tdm Co., Ltd., KR
KWQ
Mar 22, 2024K240690STRUXXURE® MCS Anterior Cervical Plate System
Nexxt Spine
KWQ
Mar 18, 2024K240515uNion® MAX Cervical Plate System
Ulrich Medical USA, Inc.
KWQ
Feb 29, 2024K233360Curiteva Thoracolumbar Plate System
Curiteva, Inc.
KWQ
Feb 22, 2024K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interb
Alphatec Spine, Inc.
KWQ
Jan 26, 2024K231715MONDRIAN™ Anterior Lumbar Plate System
Ctl Medical Corporation
KWQ
Jan 25, 2024K233735ADIRA™ Lateral Plate System
Globus Medical, Inc.
KWQ
Oct 31, 2023K232318VICTORY™ Lumbar Plate System
Globus Medical, Inc.
KWQ
Sep 12, 2023K231766Skyway Anterior Cervical Plate System
Kyocera Medical Technologies Inc. (KMTI)
KWQ
Aug 2, 2023K231593Sapphire X3 Anterior Cervical Plate System
Spinal Elements, Inc.
KWQ
Jul 19, 2023K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System
L&K BIOMED Co., Ltd., KR
KWQ
Jul 16, 2023K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate
K&J Consulting Corp.
KWQ
Jun 20, 2023K230993CODA™ Anterior Cervical Plate System
Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech
KWQ
Jun 15, 2023K231090Zevo Anterior Cervical Plate System
Medtronic Sofamor Danek USA, Inc.
KWQ
Jun 13, 2023K231145Axis Anterior Cervical Plate System
Southern Medical (Pty) , Ltd., ZA
KWQ
May 9, 2023K230721ATEC Lateral Plate System
Alphatec Spine, Inc.
KWQ
Apr 12, 2023K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral Lumbar Plate System
Omnia Medical, LLC
KWQ
Mar 14, 2023K223753Cervical Plate System
Double Medical Technology, Inc., CN
KWQ
Mar 13, 2023K223321Omnia Medical Coupler-C Anterior Cervical Plate
Omnia Medical, LLC
KWQ
Mar 7, 2023K230301Athena III Cervical Plate System
Medyssey USA, Inc.
KWQ
Mar 1, 2023K221053Magnes-C Anterior Cervical Plate System
Fellowship of Orthopaedic Researchers, Inc.
KWQ
Feb 2, 2023K223627PreView-III™ Anterior Cervical Plate System
Nexus Spine, LLC
KWQ
Jan 11, 2023K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System
Aegis Spine, Inc.
KWQ

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