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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 NameHOWMEDICA OSTEONICS CONSTRAINED ACETABULAR INSERT & TRIDENT CONSTRAINED ACETABULAR INSERT
ApplicantHOWMEDICA OSTEONICS CORP.
PMA NumberP960047
Supplement NumberS003
Date Received06/22/2001
Decision Date07/25/2001
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) a design change to the outer bearing insert of the trident(r) constrained acetabular insert - lateralizing the head center by 4 mm; 2) the addition of alumina femoral heads for use with the howmedica osteonics constrained acetabular insert and the trident(r) constrained acetabular insert.
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