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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHOWMEDICA OSTEONICS CONSTRAINED ACETABULAR INSERT & TRIDENT CONSTRAINED ACETABULAR INSERT
ApplicantHOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
ALLENDALE, NJ 07401-1677
PMA NumberP960047
Supplement NumberS003
Date Received06/22/2001
Decision Date07/25/2001
Reclassified Date 04/30/2002
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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