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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 St., Suite 1600
Westminster, CO 80021
PMA NumberP140019
Supplement NumberS005
Date Received12/09/2021
Decision Date01/07/2022
Product Code NOX 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Change in the type of Biological Indicators (BI) used in annual sterilization revalidation.
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