FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
PMA: P040033
·
Supplement: S029
·
Decision Jan 28, 2016
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
- Trade Name
- BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
- PMA Number
- P040033
- Supplement Number
- S029
- Device Class
- FDA Class 3
- Product Code
- NXT
- Generic Name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- January 28, 2016
- Date Received
- December 28, 2015
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
LOCATION CHANGE OF A PACKAGE SUPPLIER.
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 |