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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 K170306
Device Name FIBERGRAFT BG Putty Bone Graft Substitute
Applicant
Prosidyan, Inc.
30 Technology Dr.
Warren,  NJ  07059
Applicant Contact Charanpreet S. Bagga
Correspondent
Hogan Lovells US LLP
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number888.3045
Classification Product Code
MQV  
Date Received01/31/2017
Decision Date 05/24/2017
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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