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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 NumberS011
Date Received06/14/2024
Decision Date09/13/2024
Product Code NOX 
Advisory Committee Orthopedic
Clinical TrialsNCT00310440
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change to the indications for use and labeling to include use of the product in conjunction with a PEEK, titanium alloy or PEEK/titanium fusion interbody device cleared by the FDA for use in the cervical spine, and with supplemental anterior plate fixation.
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