OVDClass II

Intervertebral Fusion Device With Integrated Fixation, Lumbar

21 CFR 888.3080 / Orthopedic

OVD is the FDA product code for Intervertebral Fusion Device With Integrated Fixation, Lumbar, a class II device type, regulated under 21 CFR 888.3080. FDA's definition for this code reads: "Intended to stabilize lumbar 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 204 510(k) clearances under this code, the most recent dated 2026-08-03, and 36 recalls.

Classification record

Product code: OVD
Device name: Intervertebral Fusion Device With Integrated Fixation, Lumbar
FDA definition: Intended to stabilize lumbar 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: 205
Ingested recalls: 36

Clearances, product code OVD

By decision year

205 clearances under product code OVD with a decision year between 2007 and 2026, 2014 the highest year at 14.

Show the numbers

510(k) clearances under FDA product code OVD by decision year
Year	Clearances
2007	2
2008	8
2009	3
2010	8
2011	9
2012	10
2013	11
2014	14
2015	12
2016	13
2017	12
2018	14
2019	12
2020	14
2021	7
2022	14
2023	12
2024	12
2025	10
2026	8

Applicants with the most clearances

Product code OVD

Applicants holding the most 510(k) clearances under product code OVD
Applicant	Clearances
Globus Medical, Inc.	11
Nu Vasive, Incorporated	10
K2M, Inc	7
Medacta International SA	7
Highridge Medical, LLC	6
Alphatec Spine, Inc.	5
Renovis Surgical Technologies, LLC	5
Carlsmed, Inc.	4
Centinel Spine, LLC	4
Clariance-SAS	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 228 companies shown, in name order