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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.
 
Trade NameSBI BRAUN-CUTTER TRAPEZ-METACARPAL PROSTHESIS
Classification Nameprosthesis, finger, constrained, metal/polymer
Regulation Number888.3220
ApplicantSMALL BONE INNOVATIONS INC.
PMA NumberP960053
Supplement NumberS004
Date Received08/24/2007
Decision Date09/28/2007
Product Code
KWG[ Registered Establishments with KWG ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at professional contract sterilization, taunton, massachusetts.
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