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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
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.
41 Spring St. #107
New Providence,  NJ  07974
Applicant Contact Tamala Wampler
Correspondent
MCRA, LLC
803 7th St. NW
Floor 3
Washington,  DC  20001
Correspondent Contact Dr. Mehdi Kazemzadeh-Narbat
Regulation Number888.3045
Classification Product Code
MQV  
Date Received09/25/2025
Decision Date 10/22/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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