i-FACTOR Peptide Enhanced Bone Graft
FDA premarket approval P140019/S012 · decided 2025-02-06
Approval details
- PMA number
- P140019
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- i-FACTOR Peptide Enhanced Bone Graft
- Generic name
- Filler, bone void, synthetic peptide
- Applicant
- Cerapedics, LLC
- Date received
- 2025-01-10
- Decision date
- 2025-02-06
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NOX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminster, CO
- Statement
- Change to the sterilization equipment to add a second ARS steam sterilizer (referred to in this submission as Sterilizer 2) at the existing manufacturing facility
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