i-FACTOR® Peptide Enhanced Bone Graft
FDA premarket approval P140019/S011 · decided 2024-09-13
Approval details
- PMA number
- P140019
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- i-FACTOR® Peptide Enhanced Bone Graft
- Generic name
- Filler, bone void, synthetic peptide
- Applicant
- Cerapedics, LLC
- Date received
- 2024-06-14
- Decision date
- 2024-09-13
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- NOX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminster, CO
- Statement
- Approval for a change to the indications for use and labeling to include use of the product in conjunction with a PEEK, titanium alloy or PEEK/titanium fusion interbody device cleared by the FDA for use in the cervical spine, and with supplemental anterior plate fixation.
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