Cormet Hip Resurfacing System

FDA Premarket Approval P050016 S012

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for an update to the device labeling (i. E. , package insert) to include a summary of the results of the completed long-term post-approval study (pas).

DeviceCormet Hip Resurfacing System
Generic NameProsthesis, Hip, Semi-constrained, Metal/metal, Resurfacing
ApplicantCORIN U.S.A.
Date Received2019-01-25
Decision Date2020-07-17
PMAP050016
SupplementS012
Product CodeNXT 
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Pas
Expedited ReviewNo
Combination Product No
Applicant Address CORIN U.S.A. 12750 Citrus Park Lane suite 120 tampa, FL 33607

Supplemental Filings

Supplement NumberDateSupplement Type
P050016Original 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

Device IDPMASupp
05055196919525 P050016 010
05055196904392 P050016 010
05055196904385 P050016 010
05055196904378 P050016 010
05055196904361 P050016 010
05055196904354 P050016 010
05055196904347 P050016 010
05055196904330 P050016 010
05055196904323 P050016 010
05055196904668 P050016 010
05055196904675 P050016 010
05055196904682 P050016 010
05055196919518 P050016 010
05055196919501 P050016 010
05055196919495 P050016 010
05055196919488 P050016 010
05055196919471 P050016 010
05055196919464 P050016 010
05055196919457 P050016 010
05055196904699 P050016 010
05055196904316 P050016 010

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