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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.
 
DeviceTRIDENT SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Generic Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Applicant
HOWMEDICA OSTEONICS CORP.
325 corporate drive
mahwah, NJ 07430
PMA NumberP000013
Date Received03/02/2000
Decision Date02/03/2003
Product Code
MRA[ Registered Establishments with MRA ]
Docket Number 03M-0337
Notice Date 07/30/2003
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the osteonics abc system and trident system. These devices are indicated for patients requiring primary total hip arthroplasty due to painful disabling joint disease of the hip resulting from non-inflammatory degenerative arthritis (osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation, or diastrophic variant).
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S008 S009 S010 
S011 S012 S013 
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