K253147

FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft Substitute

510(k) number
K253147
Device name
FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft Substitute
Applicant
Prosidyan, Inc. NJ · US
Product code
MQV — Filler, Bone Void, Calcium Compound
Decision date
2025-10-22
Date received
2025-09-25
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K253147.pdf

Official FDA record: K253147
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.