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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameprosthesis, finger, constrained, metal/polymer
Generic Nameprosthesis, finger, constrained, metal/polymer
Regulation Number888.3220
bohnackerweg 1
selzach CH 25
PMA NumberP960053
Supplement NumberS003
Date Received11/08/2002
Decision Date12/31/2002
Product Code
KWG[ Registered Establishments with KWG ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new manufacturing facility located at rms co. , minneapolis, minnesota and a new sterilization facility located at micronet medical, inc. , st. Paul, minnesota.