FDA product code MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

MAX is the FDA product code for intervertebral fusion device with bone graft, lumbar. It is a Class II device, regulated under 21 CFR 888.3080 and reviewed by the Orthopedic panel. FDA has cleared 896 510(k) submissions under MAX, 155 in the last five years, from 295 different applicants. The average 510(k) review took 130 days (median 106); 121 days on average over the last three years. 6 PMA applications cite this product code. FDA has posted 115 recalls for MAX devices, 19 initiated in the last five years.

Definition

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Classification

Field	Value
Device name	Intervertebral Fusion Device With Bone Graft, Lumbar
Device class	Class II
Regulation	21 CFR 888.3080
Review panel	OR — Orthopedic
Medical specialty	Orthopedic
Premarket route	510(k)
Implant	Yes

510(k) clearances per year for MAX

Year	Clearances	Avg. review days
2017	76	134
2018	64	124
2019	60	169
2020	56	129
2021	53	129
2022	41	119
2023	30	106
2024	38	125
2025	29	101
2026	17	137

Compare with all 510(k) review times · Search every MAX clearance

Top MAX applicants

Applicant	Clearances	Latest
Nu Vasive, Incorporated	34	2022-06-21
Medtronic Sofamor Danek USA, Inc.	33	2026-07-17
Life Spine, Inc.	27	2026-07-28
Spineology, Inc.	22	2021-02-19
SeaSpine Orthopedics Corporation	20	2026-07-01

290 more applicants have MAX clearances. See the full list in Caduvo.

Most recent MAX clearances

510(k)	Applicant	Device	Decision date	Review days
K261049	Spineart SA	SCALA® TL	2026-08-20	142
K261430	Life Spine, Inc.	TruLift Expandable System	2026-07-28	89
K253011	Medtronic Sofamor Danek USA, Inc.	Catalyft PL Expandable Interbody System	2026-07-17	301
K261020	Medtronic Sofamor Danek USA, Inc.	Symmetrix L Spinal System	2026-07-14	109
K253420	SeaSpine Orthopedics Corporation	Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy	2026-07-01	273

Recalls for MAX devices

115 product recalls in 64 recall events; 19 initiated in the last five years and 18 still open. Most recent: 2025-11-03.

Year	Recalls
2017	3
2018	6
2019	8
2020	22
2021	6
2022	3
2023	6
2024	2
2025	8

Frequently asked questions

What is FDA product code MAX?

MAX is the FDA product code for intervertebral fusion device with bone graft, lumbar. It is a Class II device, regulated under 21 CFR 888.3080 and reviewed by the Orthopedic panel.

What device class is MAX?

Class II, regulation 21 CFR 888.3080. Typical premarket route: 510(k).

How long does a 510(k) take for product code MAX?

Across 896 cleared submissions the average was 130 days from receipt to decision (median 106).

Which companies have the most MAX clearances?

Nu Vasive, Incorporated (34); Medtronic Sofamor Danek USA, Inc. (33); Life Spine, Inc. (27); Spineology, Inc. (22); SeaSpine Orthopedics Corporation (20).

Have MAX devices been recalled?

Yes: 115 product recalls across 64 recall events; the most recent began 2025-11-03.

Next steps

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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