PMA P050016S009
- Device
- CORMET HIP RESURFACING SYSTEM
- Applicant
- Corin USA
- PMA number
- P050016
- Supplement
- S009
- Product code
- NXT
- Decision date
- 2013-03-22
- Classification
- Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Approval order 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.
Current openFDA PMA Record#
- Device
- CORMET HIP RESURFACING SYSTEM
- Applicant
- Corin USA
- PMA number
- P050016
- Supplement
- S009
- Product code
- NXT
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Decision date
- 2013-03-22
- Decision code
- APPR
- Date received
- 2012-02-14
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order 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.