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.
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 | 2012-02-14 |
Decision Date | 2013-03-22 |
PMA | P050016 |
Supplement | S009 |
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