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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 NameC2 A-TAPER ACETABULAR SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantBIOMET, INC.
PMA NumberP050009
Date Received03/14/2005
Decision Date12/16/2005
Product Code
MRA[ Registered Establishments with MRA ]
Docket Number 06M-0015
Notice Date 01/13/2006
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the c2a-taper acetabular system. The device is indicated for use in primary total hip arthroplasty in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and post-traumatic arthritis.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S004 S005 S007 
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