Trident Ceramic System

FDA Premarket Approval P000013 S017

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 a change of the de-nesting lubricant sprayed on polyethylene terephthalate glycol sheets that are thermoformed into blister trays used in trident alumina inserts packaging.

DeviceTrident Ceramic System
Generic NameProsthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
ApplicantHOWMEDICA OSTEONICS CORP.
Date Received2020-07-06
Decision Date2020-09-30
PMAP000013
SupplementS017
Product CodeMRA 
Advisory CommitteeOrthopedic
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address HOWMEDICA OSTEONICS CORP. 325 Corporate Drive mahwah, NJ 07430

Supplemental Filings

Supplement NumberDateSupplement Type
P000013Original Filing
S017 2020-07-06 Real-time Process
S016 2018-11-26 30-day Notice
S015 2018-09-20 30-day Notice
S014
S013 2016-02-04 30-day Notice
S012 2015-10-01 30-day Notice
S011 2011-11-10 Normal 180 Day Track No User Fee
S010 2011-10-03 Real-time Process
S009 2009-04-16 Special (immediate Track)
S008 2006-12-29 Real-time Process
S007
S006 2006-02-22 30-day Notice
S005 2004-09-09 Real-time Process
S004 2004-04-15 Real-time Process
S003 2003-08-13 Normal 180 Day Track No User Fee
S002 2003-06-12 Real-time Process
S001 2003-02-04 Real-time Process

NIH GUDID Devices

Device IDPMASupp
04546540516879 P000013 001
04546540516862 P000013 001
04546540516855 P000013 001
04546540516848 P000013 001
04546540516831 P000013 001
04546540259936 P000013 001

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