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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 NameNOVATION CERAMIC ARTICULATION HIP SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantEXACTECH, INC.
PMA NumberP050039
Date Received10/27/2005
Decision Date07/05/2007
Product Code
MRA[ Registered Establishments with MRA ]
Docket Number 07M-0287
Notice Date 07/20/2007
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 novation ceramic articulation hip system. This device is indicated for primary total hip arthroplasty in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S007 S008 S009 S010 
S011 S012 S013 S014 S015 
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