FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Filler, Bone Void, Non-Osteoinduction
PMA: P900039
·
Supplement: S003
·
Decision Dec 9, 1993
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Filler, Bone Void, Non-Osteoinduction
- Trade Name
- COLLAGRAFT(TM) BONE GRAFT SUBSTITUTE
- PMA Number
- P900039
- Supplement Number
- S003
- Device Class
- FDA Class 3
- Product Code
- MBS
- Generic Name
- Filler, bone void, non-osteoinduction
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 9, 1993
- Date Received
- October 1, 1993
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Other
- Expedited Review
- N
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 |
|---|---|---|---|
| MBS | Filler, Bone Void, Non-Osteoinduction | FDA class 3 | Unknown |