ODPClass II

Intervertebral Fusion Device With Bone Graft, Cervical

21 CFR 888.3080 / Orthopedic

ODP is the FDA product code for Intervertebral Fusion Device With Bone Graft, 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". As of 2026-09-10, FDA records hold 354 510(k) clearances under this code, the most recent dated 2026-08-26, and 11 recalls.

Classification record

Product code: ODP
Device name: Intervertebral Fusion Device With Bone Graft, Cervical
FDA definition: Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
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: 354
Ingested recalls: 11

Clearances, product code ODP

By decision year

354 clearances under product code ODP with a decision year between 2008 and 2026, 2023 the highest year at 34.

Show the numbers

510(k) clearances under FDA product code ODP by decision year
Year	Clearances
2008	8
2009	12
2010	9
2011	25
2012	17
2013	18
2014	26
2015	24
2016	17
2017	33
2018	25
2019	22
2020	14
2021	18
2022	12
2023	34
2024	10
2025	11
2026	19

Applicants with the most clearances

Product code ODP

Applicants holding the most 510(k) clearances under product code ODP
Applicant	Clearances
Orthofix SRL	10
Medtronic Sofamor Danek USA Inc	8
Nu Vasive, Incorporated	8
Gbs Commonwealth Co., Ltd.	7
Globus Medical, Inc.	7
Reliance Medical Systems, LLC	6
Spineart SA	6
Howmedica Osteonics Corp	6
Innovasis, Inc	5
VY Spine, LLC	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 311 companies shown, in name order