FDA product code MAX

Intervertebral Fusion Device With Bone Graft, Lumbar

Orthopedic·Class 2·21 CFR 888.3080·Implantable
US regulatory classifications
US Product Code (FDA)
MAX
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 888.3080
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Medical specialty
Orthopedic
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
Definition

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

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About this record

Intervertebral Fusion Device With Bone Graft, Lumbar is a medical device type in the Orthopedic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.