FDA PMA
FDA Class 2
Approved
🇺🇸 United States
Bone Cement
PMA: N18466
·
Supplement: S002
·
Decision Jun 4, 1985
Classifications
1
FEI Numbers
81
Registration Numbers
81
Basic Information
- Device Name
- Bone Cement
- Trade Name
- CMW BONE CEMENT
- PMA Number
- N18466
- Supplement Number
- S002
- Device Class
- FDA Class 2
- Product Code
- LOD
- Generic Name
- BONE CEMENT
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- June 4, 1985
- Date Received
- November 8, 1984
- 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 |
|---|---|---|---|
| LOD | Bone Cement | FDA class 2 | Orthopedic |