Data / Medical devices / Intervertebral Fusion Device With Bone Graft, Lumbar

Intervertebral Fusion Device With Bone Graft, Lumbar (MAX): 366 FDA-registered makers in 23 countries

366 establishments in 23 countries are registered with the FDA to make Intervertebral Fusion Device With Bone Graft, Lumbar (product code MAX, Class 2, 21 CFR 888.3080). 142 of them have a 510(k) clearance or PMA approval on file and 26 have a recall event. The FDA has issued 897 510(k) clearances under this code, the latest on October 21, 2026, and lists 64 recall events (1 Class I). FDA data exported November 2, 2026.

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Product code

MAX

Device class

2

Regulation

888.3080

Medical specialty

Orthopedic

Implant

Yes

Makers by country

Makers of Intervertebral Fusion Device With Bone Graft, Lumbar

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated October 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.