PMA P050016S006
- Device
- CORMET HIP RESURFACING SYSTEM
- Applicant
- Corin USA
- PMA number
- P050016
- Supplement
- S006
- Product code
- NXT
- Decision date
- 2009-12-31
- Classification
- Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Approval order statement
- APPROVAL FOR A CHANGE TO THE METHOD OF STERILIZATION OF THE INDIVIDUALLY PACKAGED FLUTED GUIDE WIRE AND REVISIONS TO THE PACKAGE LABELING.
Current openFDA PMA Record#
- Device
- CORMET HIP RESURFACING SYSTEM
- Applicant
- Corin USA
- PMA number
- P050016
- Supplement
- S006
- Product code
- NXT
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Decision date
- 2009-12-31
- Decision code
- APPR
- Date received
- 2009-11-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE TO THE METHOD OF STERILIZATION OF THE INDIVIDUALLY PACKAGED FLUTED GUIDE WIRE AND REVISIONS TO THE PACKAGE LABELING.