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Panels › Orthopedic › Product code NKG · Class 2

Posterior Cervical Screw System

Regulation 888.3075

5510(k)s in 12 months (119 all time)
0recalls in 12 months (6 all time)
6recalls that name a 510(k)
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Top companies in NKG

Company510(k)sRecalls
Orthofix, Inc.72
K2m53
Medtronic Sofamor Danek USA, Inc.70
Medacta International S.A.60
Medos International SARL60
Nu Vasive, Incorporated60
Medicrea International50
Globus Medical, Inc.40
L&K BIOMED Co., Ltd.40
Life Spine, Inc.40
Decided510(k)Device and applicantCode
Jan 24, 2020K192014SYPMHONY™ OCT System
Medos International SARL, CH
NKG
Sep 24, 2019K192354Innovasis Gibralt Spine System
Innovasis, Inc.
NKG
Aug 14, 2019K191553NuVaisve® Reline® Cervical System
Nu Vasive, Incorporated
NKG
Jul 18, 2019K190895MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System
Medos International SARL, CH
NKG
Jun 3, 2019K191185Solanas® Posterior OCT Fixation System
Alphatec Spine
NKG
May 22, 2019K190751Connector System
Orthofix, Inc.
NKG
Apr 10, 2019K190631M.U.S.T. MINI Posterior Cervical Screws System
Medacta International S.A., CH
NKG
Feb 25, 2019K190071Perla® Posterior Cervico-Thoracic Fixation System
Spineart, CH
NKG
Jan 22, 2019K182837M.U.S.T. Mini Extension
Medacta International S.A., CH
NKG
Dec 12, 2018K183383ANAX™ OCT Spinal System
U&I Corporation, KR
NKG
Nov 15, 2018K182182YUKON OCT Spinal System
K2m
NKG
Nov 13, 2018K182508Saxxony™ Posterior Cervical Thoracic System
Nexxt Spine, LLC
NKG
Oct 5, 2018K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUK
K2m, Inc.
NKG
Oct 4, 2018K181949SYMPHONY™ OCT System
Medos International SARL, CH
NKG
Jul 30, 2018K181440Proficient® Posterior Cervical Spine System
Spine Wave, Inc.
NKG
Jul 6, 2018K181350ASTRA-OCT Spine System
Spinecraft, LLC
NKG
Apr 18, 2018K180851VERTEX™ Reconstruction System
Medtronic Sofamor Danek USA, Inc.
NKG
Apr 11, 2018K172495Reform® POCT System
Precision Spine, Inc.
NKG
Mar 15, 2018K180198NuVasive® VuePoint® II OCT System
Nu Vasive, Incorporated
NKG
Feb 1, 2018K173047The Solstice OCT System
Life Spine, Inc.
NKG
Jan 22, 2018K180025Centurion POCT System
Orthofix, Inc.
NKG
Dec 19, 2017K171834G Surgical OCT Spinal System
G Surgical, LLC
NKG
Dec 15, 2017K172594Proficient® Posterior Cervical Spine System
Spine Wave, Inc.
NKG
Oct 2, 2017K171250BRIDALVEIL Occipital Cervical Thoracic System
Astura Medical
NKG
Sep 20, 2017K172279PMT Posterior Fixation System
Providence Medical Technology, Inc.
NKG
Aug 21, 2017K163375INFINITY™ OCT System
Medtronic Sofamor Danek USA, Inc.
NKG
Aug 18, 2017K172194Connector System
Orthofix, Inc.
NKG
Aug 18, 2017K172139Streamline OCT Occipito-Cervico-Thoracic System
Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
NKG
Aug 8, 2017K171444YUKON OCT Spinal System
K2m, Inc.
NKG
Aug 1, 2017K171369M.U.S.T. MINI Posterior Cervical Screws System
Medacta International S.A., CH
NKG
May 18, 2017K170804The Solstice OCT System
Life Spine, Inc.
NKG
May 11, 2017K170647Connector System
Orthofix, Inc.
NKG
May 1, 2017K162266The Cranial Fusion System
Life Spine, Inc.
NKG
Mar 3, 2017K162575Z-LINKPC System
Zavation, LLC
NKG
Feb 7, 2017K162639Proficient™ Posterior Cervical Spine System
Spine Wave, Inc.
NKG
Jan 5, 2017K161637Poseidon OCT Spinal Fixation System
Medyssey USA, Inc.
NKG
Dec 22, 2016K161032neon3™ universal OCT spinal stabilization
Ulrich GmbH & Co. KG, DE
NKG
Nov 22, 2016K162300Reform® POCT System
Precision Spine, Inc.
NKG
Nov 3, 2016K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System
L&K BIOMED Co., Ltd., KR
NKG
Sep 21, 2016K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments
Globus Medical, Inc.
NKG
Sep 6, 2016K161478Xenco Medical Posterior Cervical System
Xenco Medical, LLC
NKG
Aug 22, 2016K161498Streamline OCT Occipito-Cervico-Thoracic System
Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
NKG
Jul 21, 2016K153439PathLoc-C Posterior Cervical Fixation System
L&K BIOMED Co., Ltd., KR
NKG
Jul 11, 2016K161149PASS OCT Spinal System
Medicrea International SA, FR
NKG
Jun 28, 2016K160697Gibralt® Spine System and Gibralt® Occipital Spine System
Exactech, Inc.
NKG
May 5, 2016K160428Certex Spinal Fixation System
X-Spine Systems, Inc.
NKG
Apr 26, 2016K160756PASS OCT Spinal System
Medicrea International SA, FR
NKG
Feb 16, 2016K153631Zimmer Virage OCT Spinal Fixation System
Zimmer Spine, Inc.
NKG
Feb 16, 2016K153370Caspian OCT/MESA Mini/DENALI Mini Spinal System
K2m, Incorporated
NKG
Jan 29, 2016K153169PASS OCT Patient Specific Rods
Medicrea International, FR
NKG

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