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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 NumberS008
Date Received03/28/2023
Decision Date04/26/2023
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 to the manufacturing process for i-FACTOR® Bone Graft to allow for in-house limulus amebocyte lysate (LAL) testing.
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