Scandinavian Total Ankle Replacement (STAR Ankle)

FDA Premarket Approval P050050 S018

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

This 30-day notice is being submitted due to the breakage of the original grinding machine. The old grinding machine is no longer able to function and therefore needs to be replaced

DeviceScandinavian Total Ankle Replacement (STAR Ankle)
Generic NameProsthesis, Ankle, Uncemented, Non-constrained
ApplicantSTRYKER CORPORATION
Date Received2021-03-24
Decision Date2021-04-19
PMAP050050
SupplementS018
Product CodeNTG 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address STRYKER CORPORATION bohnackerweg 1 selzach CH 25

Supplemental Filings

Supplement NumberDateSupplement Type
P050050Original Filing
S018 2021-03-24 30-day Notice
S017 2021-02-16 30-day Notice
S016 2020-12-14 30-day Notice
S015 2020-11-02 30-day Notice
S014 2020-08-03 30-day Notice
S013
S012 2018-08-21 Real-time Process
S011 2017-10-10 Real-time Process
S010 2016-07-12 Real-time Process
S009
S008 2016-04-11 Normal 180 Day Track No User Fee
S007 2014-03-11 Normal 180 Day Track No User Fee
S006 2014-03-10 Real-time Process
S005 2012-11-13 Special (immediate Track)
S004 2012-09-04 Normal 180 Day Track No User Fee
S003
S002 2009-08-21 Normal 180 Day Track No User Fee
S001 2009-08-05 Normal 180 Day Track No User Fee

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