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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 NameOSTEONICS CONSTRAINED ACETABULAR INSERT
Classification Nameprosthesis, hip, constrained, cemented or uncemented, metal/polymer
Regulation Number888.3310
ApplicantHOWMEDICA OSTEONICS CORP.
PMA NumberP960047
Date Received12/16/1996
Decision Date06/13/1997
Reclassified Date 04/30/2002
Product Code
KWZ[ Registered Establishments with KWZ ]
Docket Number 97M-0459
Notice Date 11/17/1997
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the osteonics constrained acetabular insert. This device is indicated for use as a component of a total hip prosthesis in patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint laxity, or intraoperative instability.
Supplements: S001 S002 S003 
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