PMA P140019S008
- Device
- i-FACTOR™ Peptide Enhanced Bone Graft
- Applicant
- Cerapedics, LLC
- PMA number
- P140019
- Supplement
- S008
- Product code
- NOX
- Decision date
- 2023-04-26
- Classification
- Orthopedic
- Generic name
- Filler, bone void, synthetic peptide
- Approval order statement
- Change to the manufacturing process for i-FACTOR® Bone Graft to allow for in-house limulus amebocyte lysate (LAL) testing.
Current openFDA PMA Record#
- Device
- i-FACTOR™ Peptide Enhanced Bone Graft
- Applicant
- Cerapedics, LLC
- PMA number
- P140019
- Supplement
- S008
- Product code
- NOX
- Generic name
- Filler, bone void, synthetic peptide
- Decision date
- 2023-04-26
- Decision code
- OK30
- Date received
- 2023-03-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the manufacturing process for i-FACTOR® Bone Graft to allow for in-house limulus amebocyte lysate (LAL) testing.