ClearanceBrief
Panels › Orthopedic › Product code OVE · Class 2

Intervertebral Fusion Device With Integrated Fixation, Cervical

Regulation 888.3080

15510(k)s in 12 months (169 all time)
0recalls in 12 months (12 all time)
12recalls that name a 510(k)
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Top companies in OVE

Company510(k)sRecalls
SeaSpine Orthopedics Corporation80
Genesys Spine60
Titan Spine, Inc.42
Medtronic Sofamor Danek41
Synthes Spine50
4Web Medical40
Centinel Spine, Inc.40
Elevation Spine40
Globus Medical, Inc.40
Life Spine, Inc.40
Decided510(k)Device and applicantCode
Nov 14, 2022K221578Hexanium ACIF
Spinevision, S.A.S., FR
OVE
Aug 12, 2022K221049Zavation VariSync Plate System and VariSync Spacer System
Zavation Medical Products, LLC
OVE
Aug 5, 2022K213791Unispace SA Cervical Cage
Edisoninno Co., Ltd., KR
OVE
Feb 4, 2022K211417F3D-C2 Cervical Stand-Alone System
Corelink, LLC
OVE
Jan 10, 2022K212358Romero Cervical Cage
Spineup, Inc.
OVE
Dec 14, 2021K212904SeaSpine WaveForm C Interbody System
SeaSpine Orthopedics Corporation
OVE
Dec 9, 2021K213359SeaSpine WaveForm, C Interbody System
SeaSpine Orthopedics Corporation
OVE
Nov 19, 2021K210573Velofix SA Cervical Cage
U&I Corporation, KR
OVE
Nov 5, 2021K212853Cervical Stand-Alone System
Eminent Spine, LLC
OVE
Oct 12, 2021K212562Idys-C ZP 3DTi
Clariance, SA, FR
OVE
Sep 3, 2021K210470C-CURVE Interbody Fusion Device
Medicrea International SA, FR
OVE
Jul 23, 2021K210382Blustone Synergy Diamond SA Cervical System
Blustone Synergy, LLC
OVE
Jul 16, 2021K211111SureMAX-SA Cervical Standalone System
Additive Implants, Inc.
OVE
May 10, 2021K203311ChoiceSpine Blackhawk Ti Cervical Spacer System
Choice Spine, LLC
OVE
Jan 12, 2021K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System
Precision Spine, Inc.
OVE
Dec 18, 2020K202812IdentiTi Cervical Standalone Interbody System
Alphatec Spine, Inc.
OVE
Nov 6, 2020K203076Mecta-C Stand Alone Extension
Medacta International S.A., CH
OVE
Oct 26, 2020K202065DOLOMITE Anterior Cervical Stabilization System
Astura Medical, LLC
OVE
Oct 20, 2020K193000Hexanium® ACIF
Spinevision, S.A.S., FR
OVE
Sep 24, 2020K200115Cavetto-SA Cervical Cage System
Neurostructures, Inc.
OVE
Sep 18, 2020K201073Seaspine WaveForm C Interbody System
SeaSpine Orthopedics Corporation
OVE
Sep 14, 2020K201646Shoreline ACS (Anterior Cervical System)
SeaSpine Orthopedics Corporation
OVE
Jun 15, 2020K200087F3D Cervical Stand-Alone Interbody Fusion System
Corelink, LLC
OVE
Apr 24, 2020K193153SPIRA-C Integrated Fixation System
Camber Spine Technologies
OVE
Mar 23, 2020K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System
Nexxt Spine, LLC
OVE
Mar 4, 2020K192906Mecta-C Stand Alone
Medacta International S.A., CH
OVE
Feb 28, 2020K192570Atlas Spine Expandable Cervical Standalone Interbody System
Atlas Spine, Inc.
OVE
Jan 8, 2020K191489Genesys Spine 3DP Cervical Interbody System
Genesys Spine
OVE
Nov 13, 2019K192582NuVasive CoRoent Small Interlock System
Nu Vasive, Incorporated
OVE
Nov 13, 2019K191477AEON-C Stand Alone System
Huvexel Co. , Ltd., KR
OVE
Aug 12, 2019K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)
4Web, Inc.
OVE
Aug 7, 2019K190885Elevation Spine Saber-C System
Elevation Spine
OVE
Aug 6, 2019K191565Endoskeleton TCS Interbody Fusion Device
Titan Spine, Inc.
OVE
May 31, 2019K190546NEXXT MATRIXX Stand Alone Cervical System
Nexxt Spine, LLC
OVE
Apr 29, 2019K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System
SeaSpine Orthopedics Corporation
OVE
Oct 19, 2018K181621Stable-C Interbody System
Nexus Spine, LLC
OVE
Oct 11, 2018K182151MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate
Ctl Medical Corporation
OVE
Aug 29, 2018K181295Genesys Spine AIS-C Cervical Stand-Alone System
Genesys Spine
OVE
May 10, 2018K180642Pro-Link® Ti Stand-Alone Cervical Spacer System
Life Spine, Inc.
OVE
May 8, 2018K172484A-CIFT SoloFuse
Spinefrontier, Inc.
OVE
Mar 28, 2018K180056Genesys Spine AIS-C Cervical Anchored Interbody System
Genesys Spine
OVE
Feb 23, 2018K173077Cavetto-SA Cervical Cage System
Neurostructures, Inc.
OVE
Nov 22, 2017K172424Velofix™ SA Cervical Cage
U&I Corporation, KR
OVE
Nov 1, 2017K173175Paramount Anterior Cervical Cage System
Spine Wave, Inc.
OVE
Oct 23, 2017K171489Acapella Cervical Spacer System
Choicespine, LP
OVE
Jun 28, 2017K170830Unison-C Anterior Cervical Fixation System
Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.
OVE
Jun 15, 2017K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone System
SeaSpine Orthopedics Corporation
OVE
Jun 8, 2017K170961NuVasive CoRoent Small Interlock II System
Nu Vasive, Incorporated
OVE
Apr 21, 2017K170953Tomcat Cervical Spinal System
Choicespine, LP
OVE
Mar 10, 2017K163474CAVUX CervicalCage-L SA System
Providence Medical Technology, Inc.
OVE

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