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
Jun 22, 2018K180166Life Spine Lumbar Fixation System (SENTRY)
Life Spine, Inc.
KWQ
Apr 23, 2018K180090Cure™ Lumbar Plate System
Meditech Spine, LLC
KWQ
Apr 16, 2018K173935Mediant Anterior Cervical Plating System
Intelligent Implant Systems, LLC
KWQ
Apr 5, 2018K173867Axis Anterior Cervical Plate System
Axis Orthopaedics
KWQ
Apr 3, 2018K173885Genesys Spine Binary Lumbar Plate System
Genesys Spine
KWQ
Mar 27, 2018K180537Zavation Buttress Plate System
Zavation Medical Products, LLC
KWQ
Feb 26, 2018K171797TRYPTIK2 C-Plate Anterior Cervical Plate System
Spineart, CH
KWQ
Jan 24, 2018K173521SeaSpine Cabo ACP (Anterior Cervical Plate) System
SeaSpine Orthopedics Corporation
KWQ
Jan 22, 2018K173306EZ Plate
Zavation Medical Products, LLC
KWQ
Dec 21, 2017K173375Anterior Cervical Plate System
Evolution Spine, LLC
KWQ
Dec 6, 2017K173091Boundary Anterior Lumbar Buttress Plate
Nvision Biomedical Technologies, LLC
KWQ
Nov 30, 2017K173099Fortis and Hana Anterior Cervical Plate System
Huvexel Co. , Ltd., KR
KWQ
Oct 23, 2017K172585Liberty Anterior Cervical Plate
Valorus Spine
KWQ
Oct 5, 2017K163366Shanghai Sanyou CARMEN Cervical Fusion System
Shanghai Sanyou Medical Co, Ltd., CN
KWQ
Sep 22, 2017K172086Matira™ Anterior Cervical System
Kalitec Direct, LLC
KWQ
Aug 28, 2017K1721312 Hole Lateral Plating System
Life Spine, Inc.
KWQ
Aug 23, 2017K172104Ozark(tm) Cervical Plate System
K2m, Inc.
KWQ
Aug 11, 2017K163625NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System
Signature Orthopaedics Pty, Ltd., AU
KWQ
Jul 20, 2017K171439EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plat
Medos International SARL, CH
KWQ
Jul 6, 2017K170224Spider Cervical Plating System
X-Spine Systems, Inc.
KWQ
Jun 21, 2017K163104Terrace™ Anterior Cervical Plate System
Corelink, LLC
KWQ
Jun 16, 2017K171538Cure™ Lumbar Plate System
Meditech Spine, LLC
KWQ
Jun 8, 2017K171112Trifore(tm) Cervical Plating System
Neurostructures, Inc.
KWQ
May 9, 2017K170342Ocata Anterior Cervical System
Kalitec Direct, LLC
KWQ
Mar 22, 2017K170530Butrex Lumbar Buttress Plating System
X-Spine Systems, Inc.
KWQ
Feb 17, 2017K162824Z-Span Plate System
Zavation, LLC
KWQ
Feb 16, 2017K163602Kepler I Cervical Plate System
Orbbo Surgical, LLC
KWQ
Feb 6, 2017K163061Altus Spine Cervical Plate System
Altus Partners, LLC
KWQ
Jan 5, 2017K161641LOSPA IS ACP System
Corentec Co., Ltd., KR
KWQ
Dec 22, 2016K160982Sphynx™
Eden Spine, LLC
KWQ
Dec 16, 2016K162638CETRA Anterior Cervical Plate System
Orthofix, Inc.
KWQ
Dec 8, 2016K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System
Medicrea International SA, FR
KWQ
Nov 28, 2016K162211AccuFit Lateral Plate System
Precision Spine, Inc.
KWQ
Oct 26, 2016K162250FortiBridge Anterior Cervical Plate System
Nanovis Spine, LLC
KWQ
Oct 7, 2016K162664Pyrenees Cervical Plate System
K2m, Inc.
KWQ
Sep 2, 2016K161524Tangis Anterior Cervical Plate
Nvision Biomedical Technologies, LLC
KWQ
Aug 23, 2016K160702ZION Anterior Cervical Fixation System
Astura Medical
KWQ
Jul 15, 2016K153097Belvedere™ Lateral Plating System
Neurostructures, Inc.
KWQ
Jul 1, 2016K160604Cure™ Anterior Cervical Plate (ACP) System
Meditech Spine, LLC
KWQ
Apr 27, 2016K153526Pyrenees Cervical Plate System
K2m
KWQ
Apr 26, 2016K160522White Pearl Preferred Angle Anterior Cervical Plate
Osseus Fusion Systems, LLC
KWQ
Mar 28, 2016K153042TRYPTIK2C-plate Anterior Cervical Plate System
Spineart, CH
KWQ
Mar 22, 2016K160362Z-Span Plate System
Zavation, LLC
KWQ
Feb 10, 2016K151553Anterior Cervical Plate System
Osteomed Implantes, Ltda, BR
KWQ
Dec 2, 2015K152239Zero-P Natural Plate System
Synthes (Usa), LLC
KWQ
Nov 20, 2015K152282Cam Lock Plating System
Life Spine, Inc.
KWQ
Nov 12, 2015K152623ATLANTIS Anterior Cervical Plate System
Medtronic Sofamor Danek USA, Inc.
KWQ
Oct 15, 2015K152455Amendia Cervical Plate System
Amendia, Inc.
KWQ
Sep 25, 2015K152193Renovis Anterior Cervical Plate System
Renovis Surgical Technologies, Inc.
KWQ
Sep 24, 2015K152281Pyrenees Cervical Plate System
K2m
KWQ

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