← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

MPW — Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

Pma approved: P000054

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
1
510(K)/PMA CLEARANCES
pma: 1
0
RECALL ENTRIES

Recent clearances

P000054Medtronic Sofamor Danek USA, Inc. · pma2026-03-19

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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