FDA PMA
FDA Class 3
Approved (Reclassification)
🇺🇸 United States
Filler, Bone Void, Non-Osteoinduction
PMA: P900039
·
Decision May 28, 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
- Device Class
- FDA Class 3
- Product Code
- MBS
- Generic Name
- Filler, bone void, non-osteoinduction
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved (Reclassification)
- Decision Code
- APRL
- Decision Date
- May 28, 1993
- Date Received
- May 25, 1990
- Expedited Review
- N
- Docket Number
- 93M-0210
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 |