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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
Devicei-FACTOR® Peptide Enhanced Bone Graft
Generic NameFiller, bone void, synthetic peptide
ApplicantCERAPEDICS, LLC
11025 DOVER STREET
SUITE 1600
WESTMINSTER, CO 80021
PMA NumberP140019
Supplement NumberS007
Date Received10/19/2022
Decision Date11/15/2022
Product Code NOX 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Change to the manufacturing process for i-FACTOR® Bone Graft to allow blending of up to four batches of P-15 coated anorganic bone mineral (ABM).
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