FDA PMA
FDA Class 2
Approved (Reclassification)
🇺🇸 United States
Bone Cement
PMA: N17113
·
Decision Sep 16, 1981
Classifications
1
FEI Numbers
81
Registration Numbers
81
Basic Information
- Device Name
- Bone Cement
- Trade Name
- OMNIPLASTIC BONE CEMENT
- PMA Number
- N17113
- Device Class
- FDA Class 2
- Product Code
- LOD
- Generic Name
- BONE CEMENT
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Advisory Committee
- Orthopedic
- Decision
- Approved (Reclassification)
- Decision Code
- APRL
- Decision Date
- September 16, 1981
- Date Received
- February 27, 1981
- Expedited Review
- N
- Docket Number
- 81M-0308
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 |
|---|---|---|---|
| LOD | Bone Cement | FDA class 2 | Orthopedic |