Premarket Approval (PMA)

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.

• Device: I-FACTOR PEPTIDE ENHANCED BONE GRAFT
• Generic Name: Filler, bone void, synthetic peptide
• Applicant: Cerapedics, LLC; 11025 Dover St., Suite 1600; Westminster, CO 80021
• PMA Number: P140019
• Supplement Number: S002
• Date Received: 01/19/2016
• Decision Date: 03/18/2016
• Product Code: NOX
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for the inclusion of additional graft sizes, i.e., 1.0 and 2.5cc, to the approved 5.0cc graft.