FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
PMA: P050016
·
Supplement: S001
·
Decision Oct 18, 2007
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
- Trade Name
- CORMET HIP RESURFACING SYSTEM
- PMA Number
- P050016
- Supplement Number
- S001
- Device Class
- FDA Class 3
- Product Code
- NXT
- Generic Name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- October 18, 2007
- Date Received
- July 16, 2007
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol - OSB
- Expedited Review
- N
Advisory Committee Statement
APPROVAL OF THE POST-APPROVAL STUDY.
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 |
|---|---|---|---|
| NXT | Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing | FDA class 3 | Unknown |