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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 K213803
Device Name FIBERGRAFT Aeridyan Matrix Bone Graft Substitute
Applicant
Prosidyan, Inc.
41 Spring St. Suite #107
New Providence,  NJ  07974
Applicant Contact Charanpreet S. Bagga
Correspondent
Hogan Lovells US LLP
1735 Market St., Suite 2300
Hiladelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number888.3045
Classification Product Code
MQV  
Date Received12/06/2021
Decision Date 08/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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