OVEClass II

Intervertebral Fusion Device With Integrated Fixation, Cervical

21 CFR 888.3080 / Orthopedic

OVE is the FDA product code for Intervertebral Fusion Device With Integrated Fixation, Cervical, a class II device type, regulated under 21 CFR 888.3080. FDA's definition for this code reads: "Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation". As of 2026-09-10, FDA records hold 166 510(k) clearances under this code, the most recent dated 2026-08-21, and 12 recalls.

Classification record

Product code: OVE
Device name: Intervertebral Fusion Device With Integrated Fixation, Cervical
FDA definition: Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Regulation: 21 CFR 888.3080
Device class: Class II
Review panel: Orthopedic
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 167
Ingested recalls: 12

Clearances, product code OVE

By decision year

167 clearances under product code OVE with a decision year between 2007 and 2026, 2023 the highest year at 16.

Show the numbers

510(k) clearances under FDA product code OVE by decision year
Year	Clearances
2007	1
2008	4
2009	1
2010	4
2011	8
2012	7
2013	5
2014	11
2015	12
2016	15
2017	9
2018	7
2019	7
2020	13
2021	10
2022	10
2023	16
2024	6
2025	10
2026	11

Applicants with the most clearances

Product code OVE

Applicants holding the most 510(k) clearances under product code OVE
Applicant	Clearances
SeaSpine Orthopedics Corporation	8
Genesys Spine	6
Spinal Elements, Inc	5
4Web Medical, Inc.	4
Centinel Spine, LLC	4
Globus Medical, Inc.	4
Life Spine	4
Nexus Spine, L.L.C.	4
Nu Vasive, Incorporated	4
Synthes Spine Co.Lp	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 213 companies shown, in name order