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FDA PRODUCT CODE · CLASS II

MAX — Intervertebral Fusion Device With Bone Graft, Lumbar

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

DEVICE CLASS
Class II
REGULATION
21 CFR 888.3080
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
59
510(K)/PMA CLEARANCES
510k: 59
0
RECALL ENTRIES

Recent clearances

K253011Medtronic Sofamor Danek USA, Inc. · 510k2026-07-17
K261020Medtronic Sofamor Danek USA, Inc. · 510k2026-07-14
K253420SeaSpine Orthopedics Corporation · 510k2026-07-01
K253151Beijing Fule Science & Technology Development Co., Ltd. · 510k2026-06-15
K261159Spine Wave, Inc. · 510k2026-05-29
K253894Global Biomedica s.r.o. · 510k2026-05-28
K260506Spinal Elements, Inc. · 510k2026-05-15
K260837Life Spine, Inc. · 510k2026-05-12

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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