FDA PMA
FDA Class 2
Approved
🇺🇸 United States
Bone Cement
PMA: P810020
·
Supplement: S005
·
Decision Oct 15, 1998
Classifications
1
FEI Numbers
81
Registration Numbers
81
Basic Information
- Device Name
- Bone Cement
- Trade Name
- OSTEOPAL
- PMA Number
- P810020
- Supplement Number
- S005
- 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
- October 15, 1998
- Date Received
- September 14, 1998
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for changes to Osteopal's package insert.
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 |