TOTAL TRAPEZIO METACARPAL PROSTHESIS

FDA Premarket Approval P960053 S001

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 1) packaging the implant in a single box containing both the proximal and distal components and changing package labels accordingly, and 2) changing the color of stock used for printing box labels.

DeviceTOTAL TRAPEZIO METACARPAL PROSTHESIS
Generic NameProsthesis, Finger, Constrained, Metal/polymer
ApplicantSTRYKER CORPORATION
Date Received1998-03-31
Decision Date1998-06-04
PMAP960053
SupplementS001
Product CodeKWG 
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track
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
P960053Original Filing
S005 2016-07-13 Special (immediate Track)
S004 2007-08-24 Normal 180 Day Track No User Fee
S003 2002-11-08 Normal 180 Day Track
S002 1998-04-16 Normal 180 Day Track
S001 1998-03-31 Normal 180 Day Track

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