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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameBRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS
Classification Nameprosthesis, finger, constrained, metal/polymer
Regulation Number888.3220
ApplicantSMALL BONE INNOVATIONS INC.
PMA NumberP960053
Date Received12/24/1996
Decision Date06/19/1997
Product Code
KWG[ Registered Establishments with KWG ]
Docket Number 97M-0393
Notice Date 09/23/1997
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the avanta braun-cutter trapezo-metacarpal prosthesis. This device is indicated for total joint replacement in skeletally mature patients with pain or instability of the trapezo-metacarpal joint due to trauma, inflammatory or degenerative disease or revision of previous procedures, as an alternative to arthrodesis or reconstructive surgery.
Supplements: S001 S002 S003 S004 
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