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 Globus Medical, Inc..
166
Total
166
Cleared
134d
Avg days
2007
Since
Declining activity -
21 submissions in the last 2 years
vs 27 in the prior period
Review times improving: avg
116d
recently vs 137d historically
FDA 510(k) Cleared Intervertebral Fusion Device With Integrated Fixation, Cervical Devices (Product Code OVE)
166 devices
Cleared
Aug 21, 2026
Pisces-SC Standalone Cervical Interbody System
Osseus Fusions Systems, LLC
Orthopedic
77d
Cleared
Jul 31, 2026
ZSAlign Cervical Interbody System
Zsfab, Inc.
Orthopedic
91d
Cleared
Jul 22, 2026
E3D™-C Interbody System
Evolution Spine
Orthopedic
30d
Cleared
Jun 22, 2026
DeltaNEC Interbody System
Nexus Spine
Orthopedic
66d
Cleared
Jun 18, 2026
CONDUIT™ ZERO-P™ VA Secured Spacer System
Avalign Technologies, Inc.
Orthopedic
274d
Cleared
Jun 15, 2026
NeckTune™ 3D SA Cervical Cage
Medyssey Co, Ltd.
Orthopedic
160d
Cleared
Apr 27, 2026
SABER-C System
Elevation Spine
Orthopedic
56d
Cleared
Apr 20, 2026
SAGI Cervical Cage System
ZheJiang Decans Medical Devices Co., Ltd.
Orthopedic
203d
Cleared
Apr 15, 2026
Uni-C Cervical Cage System
ZheJiang Decans Medical Devices Co., Ltd.
Orthopedic
225d
Cleared
Feb 04, 2026
E3D™-C Interbody System
Evolution Spine
Orthopedic
29d
Cleared
Dec 22, 2025
HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)
Globus Medical, Inc.
Orthopedic
18d
Cleared
Dec 11, 2025
Cervical Spine Truss System - Stand Alone (CSTS-SA)
4Web Medical, Inc.
Orthopedic
76d
Cleared
Sep 25, 2025
Endeavor™ Stand-Alone Cervical IBF System
Innovasis
Orthopedic
258d
Cleared
Aug 08, 2025
SABER-C System
Elevation Spine
Orthopedic
165d
Cleared
Jul 30, 2025
Stabilis SA Cervical Stand-Alone System (Various PNs)
Acuity Surgical Devices, LLC
Orthopedic
54d
Cleared
Jun 27, 2025
FIX-C PEEK ACIF SA System
Jeil Medical Corporation
Orthopedic
50d
Cleared
Apr 25, 2025
Cervical Spine Truss System (CSTS)
4Web Medical
Orthopedic
14d
Cleared
Apr 10, 2025
Tesera-k SC System
Kyocera Medical Technologies, Inc.
Orthopedic
198d
Cleared
Feb 11, 2025
CYLOX® ST
Signus Medizintechnik GmbH
Orthopedic
134d
Cleared
Feb 07, 2025
Genesys Spine AIS-C II Cervical Interbody Fusion System
Genesys Spine
Orthopedic
170d
Cleared
Nov 20, 2024
ProAM ACDF System
Pro Surgical, Inc.
Orthopedic
89d
Cleared
Aug 12, 2024
E3D™-C Interbody System
Evolution Spine
Orthopedic
47d
Cleared
Jul 17, 2024
Stable-C Interbody System
Nexus Spine, LLC
Orthopedic
55d
Cleared
May 10, 2024
SCARLET® AC-Ti
Spineart SA
Orthopedic
57d
About Product Code OVE - Regulatory Context
510(k) Submission Activity
166 total 510(k) submissions under product code OVE since 2007, with 166 receiving FDA clearance (average review time: 134 days).
Submission volume has declined in recent years - 21 submissions in the last 24 months compared to 27 in the prior period.
FDA 510(k) Review Time - OVE Product Code
Recent submissions under OVE have taken an average of 116 days to reach a decision - down from 137 days historically, suggesting improved FDA processing for this classification.
OVE devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →