FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
PMA: P050016
·
Supplement: S009
·
Decision Mar 22, 2013
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
- S009
- 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
- March 22, 2013
- Date Received
- February 14, 2012
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE REPROCESSING OF UNUSED CORMET RESURFACING HEADS THAT ARE APPROACHING THEIR EXPIRATION DATE. THE UNUSED CORMET RESURFACING HEADS WILL BE OPENED FROM THE PACKAGING, CLEANED, REPACKED, RE-STERILIZED AND RELABELED WITH A 5 YEAR SHELF LIFE.
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 |