PMA P140019S002
- Device
- I-FACTOR PEPTIDE ENHANCED BONE GRAFT
- Applicant
- Cerapedics, LLC
- PMA number
- P140019
- Supplement
- S002
- Product code
- NOX
- Decision date
- 2016-03-18
- Classification
- Filler, Bone Void, Synthetic Peptide
- Generic name
- Filler, bone void, synthetic peptide
- Approval order statement
- Approval for the inclusion of additional graft sizes, i.e., 1.0 and 2.5cc, to the approved 5.0cc graft.
Current openFDA PMA Record#
- Device
- I-FACTOR PEPTIDE ENHANCED BONE GRAFT
- Applicant
- Cerapedics, LLC
- PMA number
- P140019
- Supplement
- S002
- Product code
- NOX
- Generic name
- Filler, bone void, synthetic peptide
- Decision date
- 2016-03-18
- Decision code
- APPR
- Date received
- 2016-01-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the inclusion of additional graft sizes, i.e., 1.0 and 2.5cc, to the approved 5.0cc graft.