Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 STREET
SUITE 1600
WESTMINSTER, CO 80021
PMA NumberP140019
Supplement NumberS001
Date Received12/03/2015
Decision Date03/17/2016
Product Code NOX 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval of the protocol for the ODE Lead PMA Post-Approval Study.
-
-