FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Filler, Bone Void, Synthetic Peptide
PMA: P140019
·
Supplement: S008
·
Decision Apr 26, 2023
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Filler, Bone Void, Synthetic Peptide
- Trade Name
- i-FACTOR Peptide Enhanced Bone Graft
- PMA Number
- P140019
- Supplement Number
- S008
- Device Class
- FDA Class 3
- Product Code
- NOX
- Generic Name
- Filler, bone void, synthetic peptide
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- April 26, 2023
- Date Received
- March 28, 2023
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Change to the manufacturing process for i-FACTOR® Bone Graft to allow for in-house limulus amebocyte lysate (LAL) testing.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NOX | Filler, Bone Void, Synthetic Peptide | FDA class 3 | Unknown |