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BioIncyte

ROYAL BIOLOGICS INC. · Model 510356 · UDI-DI 00850014593629

ORG Prescription

510(k) clearances

435

Adverse events

Recalls

106

Facilities

Description

The BioIncyte Autologous Fibrin & Platelet System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.