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
Dec 7, 2022K220843OAKTREE Anterior Lumbar Plate and Screw System
Oak Tree Engineering, LLC
KWQ
Nov 18, 2022K222493CODA™ Anterior Cervical Plate System
Pioneer Surgical Technology, Inc.
KWQ
Nov 16, 2022K222628Life Spine ALIF Buttress Plate System
Life Spine, Inc.
KWQ
Nov 9, 2022K220334MONET Anterior Cervical Plate System
Ctl Medical Corporation
KWQ
Oct 19, 2022K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, R
Stryker Corporation
KWQ
Oct 18, 2022K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar P
Dio Medical Corporation
KWQ
Sep 16, 2022K220441CYGNUS™ MoRe Anterior Cervical Plate System
MiRus, LLC
KWQ
Jul 26, 2022K221572VyPlate Anterior Cervical Plate System
Vy Spine, LLC
KWQ
Jun 28, 2022K211718Venus Cervical Plate System
Artfx Medical, LLC
KWQ
May 17, 2022K212527Cervical Spine Truss System Plating Solution (CSTS-PS)
4Web Medical, Inc.
KWQ
Mar 30, 2022K220182Aggeris™-C
Clariance, FR
KWQ
Mar 25, 2022K213820BALTEUM - ONE™ Lumbar Plate System
Huvexel Co. , Ltd., KR
KWQ
Mar 18, 2022K220275EMERGE Anterior Cervical Plate System
Evolution Spine
KWQ
Mar 16, 2022K220324AccuFit Lateral 2-Hole Plate
Precision Spine, Inc.
KWQ
Mar 3, 2022K220379IMPEACE and IMPEACE-Uni Anterior Cervical Plate System
Medynus, Inc.
KWQ
Feb 16, 2022K220147Aspiron S ACP System
U&I Corporation, KR
KWQ
Feb 11, 2022K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallma
Orthofix US, LLC
KWQ
Jan 7, 2022K213901Cyclops™ Anterior Cervical Plate System
Degen Medical
KWQ
Dec 23, 2021K213219Vy Spine™ VyWasher™ Buttress System
Vy Spine, LLC
KWQ
Dec 21, 2021K213456Xenco Medical Multilevel CerviKit
Xenco Medical, LLC
KWQ
Dec 15, 2021K213443Insignia™ Anterior Cervical Plate System
Alphatec Spine, Inc.
KWQ
Nov 4, 2021K212937Dakota ALIF Plate System
Precision Spine, Inc.
KWQ
Nov 3, 2021K212446NuVasive Anterior Cervical Plate Systems
Nu Vasive, Incorporated
KWQ
Oct 22, 2021K210424Quantum Anterior Cervical Plate
Nvision Biomedical Technologies, Inc.
KWQ
Sep 30, 2021K212405EMERGE™ Anterior Cervical Plate System
Evolution Spine
KWQ
Sep 1, 2021K212139Admiral ACP System
SeaSpine Orthopedics Corporation
KWQ
Aug 30, 2021K211903Shoreline Threaded TruProfile® Plate
SeaSpine Orthopedics Corporation
KWQ
Aug 12, 2021K211205Prase-C Anterior Cervical Plate System
Gbs Commonwealth Co., Ltd., KR
KWQ
Jul 27, 2021K211932Fixxsure Anterior Lumbar Plate and Screw System
Oak Tree Engineering, LLC
KWQ
Jun 23, 2021K211408CervAlign® Anterior Cervical Plate System
Pioneer Surgical Technology, Inc.
KWQ
Apr 7, 2021K210182PANAMA™ Anterior Cervical Plate (ACP) System
Flospine
KWQ
Mar 23, 2021K210325APOLLO Anterior Cervical Plate (ACP) System
Aurora Spine, Inc.
KWQ
Mar 18, 2021K210286Cure 2.0 Anterior Cervical Plate (ACP) System
Meditech Spine, LLC
KWQ
Mar 10, 2021K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)
4Web, Inc.
KWQ
Jan 29, 2021K202878Prase-AP Anterior Cervical Plate System
Gbs Commonwealth Co., Ltd., KR
KWQ
Dec 3, 2020K203253NuVasive ACP System
Nu Vasive, Incorporated
KWQ
Nov 24, 2020K202972Anterior Cervical Plate System
Nutech Spine and Biologics
KWQ
Nov 5, 2020K203154KASILOF Cervical Plate System
Kahtnu Surgical, Inc.
KWQ
Nov 4, 2020K202624Z-Span Plate System
Zavation Medical Products, LLC
KWQ
Oct 15, 2020K201587icotec Anterior Cervical Plate System
Icotec AG, CH
KWQ
Oct 8, 2020K202309Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Ad
Zimmer Biomet Spine, Inc.
KWQ
Sep 17, 2020K202192STRUXXURE®-L and STRUXXURE®-A Plate System
Nexxt Spine, LLC
KWQ
Sep 14, 2020K202227Artus™ cervical plate system
Ulrich GmbH & Co. KG, DE
KWQ
Aug 26, 2020K202064Admiral ACP System
SeaSpine Orthopedics Corporation
KWQ
Aug 25, 2020K201979Cervical Plate System
Eminent Spine, LLC
KWQ
Aug 6, 2020K201521Medina Anterior Cervical Plate System
Alliance Partners, LLC
KWQ
Aug 5, 2020K201079Aurora® Anterior Lumbar Plate Sytstem
Prism Surgical Design Pty , Ltd., AU
KWQ
Jul 28, 2020K192481AccelFix Lumbar Plate System
L&K BIOMED Co., Ltd., KR
KWQ
Jul 24, 2020K200927Transept Cervical Plate System
Neurostructures, Inc.
KWQ
Jun 17, 2020K201029Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System
Spinal Elements, Inc.
KWQ

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