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.
| Device | CORMET HIP RESURFACING SYSTEM |
| Classification Name | Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing |
| Applicant | CORIN U.S.A. |
| Date Received | 2013-12-13 |
| Decision Date | 2014-04-03 |
| PMA | P050016 |
| Supplement | S010 |
| Product Code | NXT |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CORIN U.S.A. 12750 Citrus Park Lane suite 120 tampa, FL 33607 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P050016 | | Original Filing |
| S012 |
2019-01-25 |
Normal 180 Day Track No User Fee |
| S011 |
2016-07-06 |
Normal 180 Day Track No User Fee |
| S010 |
2013-12-13 |
Real-time Process |
| S009 |
2012-02-14 |
Real-time Process |
| S008 |
2011-10-11 |
30-day Notice |
| S007 |
2010-11-19 |
Real-time Process |
| S006 |
2009-11-02 |
Real-time Process |
| S005 |
2009-11-02 |
Special (immediate Track) |
| S004 |
2008-09-29 |
Normal 180 Day Track No User Fee |
| S003 |
2008-05-16 |
Real-time Process |
| S002 |
2007-09-04 |
Real-time Process |
| S001 |
2007-07-16 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices