FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
PMA: P050016
·
Supplement: S010
·
Decision Apr 3, 2014
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
- S010
- 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
- April 3, 2014
- Date Received
- December 13, 2013
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR AN ADDITION TO THE LABELING FOR THE CORMET HIP RESURFACING SYSTEM TO INCLUDE MR CONDITIONAL LANGUAGE IN THE WARNINGS AND PRECAUTIONS FOR THE SYSTEM.
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 |