OVE · Class II · 21 CFR 888.3080

FDA Product Code OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

FDA product code OVE covers cervical intervertebral fusion devices with integrated fixation.

These single-piece implants combine an interbody spacer with integrated anterior fixation screws or blades, providing both disc space support and vertebral stabilization without a separate plate. They are used in one- or two-level anterior cervical discectomy and fusion procedures.

OVE devices are Class II medical devices, regulated under 21 CFR 888.3080 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include SeaSpine Orthopedics Corporation, Genesys Spine and Nu Vasive, Incorporated.

166
Total
166
Cleared
134d
Avg days
2007
Since
166 devices
73–96 of 166
Cleared Mar 04, 2020
Mecta-C Stand Alone
K192906
Medacta International S.A.
Orthopedic · 141d
Cleared Feb 28, 2020
Atlas Spine Expandable Cervical Standalone Interbody System
K192570
Atlas Spine, Inc.
Orthopedic · 163d
Cleared Jan 08, 2020
Genesys Spine 3DP Cervical Interbody System
K191489
Genesys Spine
Orthopedic · 218d
Cleared Nov 13, 2019
AEON-C Stand Alone System
K191477
Huvexel Co. , Ltd.
Orthopedic · 162d
Cleared Nov 13, 2019
NuVasive CoRoent Small Interlock System
K192582
Nu Vasive, Incorporated
Orthopedic · 55d
Cleared Aug 12, 2019
Cervical Spinal Truss System-Stand Alone (CSTS-SA)
K190870
4Web, Inc.
Orthopedic · 131d
Cleared Aug 07, 2019
Elevation Spine Saber-C System
K190885
Elevation Spine
Orthopedic · 125d
Cleared Aug 06, 2019
Endoskeleton TCS Interbody Fusion Device
K191565
Titan Spine, Inc.
Orthopedic · 54d
Cleared May 31, 2019
NEXXT MATRIXX Stand Alone Cervical System
K190546
Nexxt Spine, LLC
Orthopedic · 87d
Cleared Apr 29, 2019
SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System
K190655
SeaSpine Orthopedics Corporation
Orthopedic · 46d
Cleared Oct 19, 2018
Stable-C Interbody System
K181621
Nexus Spine, LLC
Orthopedic · 121d
Cleared Oct 11, 2018
MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate
K182151
Ctl Medical Corporation
Orthopedic · 64d
Cleared Aug 29, 2018
Genesys Spine AIS-C Cervical Stand-Alone System
K181295
Genesys Spine
Orthopedic · 105d
Cleared May 10, 2018
Pro-Link® Ti Stand-Alone Cervical Spacer System
K180642
Life Spine, Inc.
Orthopedic · 59d
Cleared May 08, 2018
A-CIFT SoloFuse
K172484
Spinefrontier, Inc.
Orthopedic · 264d
Cleared Mar 28, 2018
Genesys Spine AIS-C Cervical Anchored Interbody System
K180056
Genesys Spine
Orthopedic · 79d
Cleared Feb 23, 2018
Cavetto-SA Cervical Cage System
K173077
Neurostructures, Inc.
Orthopedic · 147d
Cleared Nov 22, 2017
Velofix™ SA Cervical Cage
K172424
U&I Corporation
Orthopedic · 104d
Cleared Nov 01, 2017
Paramount Anterior Cervical Cage System
K173175
Spine Wave, Inc.
Orthopedic · 33d
Cleared Oct 23, 2017
Acapella Cervical Spacer System
K171489
Choicespine, LP
Orthopedic · 154d
Cleared Jun 28, 2017
Unison-C Anterior Cervical Fixation System
K170830
Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
Orthopedic · 100d
Cleared Jun 15, 2017
SeaSpine Shoreline ACS - Anterior Cervical Standalone System
K170569
SeaSpine Orthopedics Corporation
Orthopedic · 108d
Cleared Jun 08, 2017
NuVasive CoRoent Small Interlock II System
K170961
Nu Vasive, Incorporated
Orthopedic · 69d
Cleared Apr 21, 2017
Tomcat Cervical Spinal System
K170953
Choicespine, LP
Orthopedic · 21d