1 device · 1 company · 2025
Product code MAX: Intervertebral Fusion Device With Bone Graft, Lumbar
1 device under product code MAX, 2025, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Intervertebral Fusion Device With Bone Graft, Lumbar. 21 CFR 888.3080, Class II. Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft. MAUDE held 9,297 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| GoLIF! Lumbar Interbody Fusion SystemK250186 · 510(k) | GetSet Surgical, SA | Orthopedic | database entry |
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