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: S001
• Date Received: 12/03/2015
• Decision Date: 03/17/2016
• Product Code: NOX
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of the protocol for the ODE Lead PMA Post-Approval Study.