FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Filler, Bone Void, Synthetic Peptide
PMA: P140019
·
Supplement: S002
·
Decision Mar 18, 2016
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
- S002
- Device Class
- FDA Class 3
- Product Code
- NOX
- Generic Name
- Filler, bone void, synthetic peptide
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 18, 2016
- Date Received
- January 19, 2016
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval for the inclusion of additional graft sizes, i.e., 1.0 and 2.5cc, to the approved 5.0cc graft.
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 |