MAXClass II

Intervertebral Fusion Device With Bone Graft, Lumbar

21 CFR 888.3080 / Orthopedic

MAX is the FDA product code for Intervertebral Fusion Device With Bone Graft, Lumbar, a class II device type, regulated under 21 CFR 888.3080. FDA's definition for this code reads: "Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft". As of 2026-09-10, FDA records hold 896 510(k) clearances under this code, the most recent dated 2026-08-20, and 115 recalls.

Classification record

Product code: MAX
Device name: Intervertebral Fusion Device With Bone Graft, Lumbar
FDA definition: Intended to stabilize 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: 896
Ingested recalls: 115

Clearances, product code MAX

By decision year

896 clearances under product code MAX with a decision year between 2007 and 2026, 2017 the highest year at 76.

Show the numbers

510(k) clearances under FDA product code MAX by decision year
Year	Clearances
2007	7
2008	35
2009	31
2010	29
2011	49
2012	48
2013	58
2014	58
2015	53
2016	64
2017	76
2018	64
2019	60
2020	56
2021	53
2022	41
2023	30
2024	38
2025	29
2026	17

Applicants with the most clearances

Product code MAX

Applicants holding the most 510(k) clearances under product code MAX
Applicant	Clearances
Medtronic Sofamor Danek USA Inc	37
Nu Vasive, Incorporated	34
Life Spine	33
Spineology, Inc.	22
Alphatec Spine, Inc.	21
Spinal Elements, Inc	21
Globus Medical, Inc.	20
SeaSpine Orthopedics Corporation	20
Medtronic Sofamor Danek	18
Stryker Corp.	17

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 383 companies shown, in name order