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FDA PRODUCT CODE · UNCLASSIFIED

PBD — Composite Cultured Skin

For patients with mitten hand deformities due to Recessive Dystrophic Epidermolysis Bullosa (RDEB)

DEVICE CLASS
Unclassified
REGULATION
21 CFR 878.4024
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

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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