FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented
PMA: P820024
·
Supplement: S008
·
Decision Nov 17, 1986
Classifications
1
FEI Numbers
1
Registration Numbers
1
Basic Information
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented
- Trade Name
- PROSTHESIS, HIP, HEMI-FEMORAL, METAL
- PMA Number
- P820024
- Supplement Number
- S008
- Device Class
- FDA Class 3
- Product Code
- LPF
- Generic Name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic, cemented
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 17, 1986
- Date Received
- August 5, 1986
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- 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 |
|---|---|---|---|
| LPF | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented | FDA class 3 | Unknown |