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Device | NOVATION CERAMIC ARTICULATION HIP SYSTEM |
Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. GAINESVILLE, FL 32653 |
PMA Number | P050039 |
Date Received | 10/27/2005 |
Decision Date | 07/05/2007 |
Withdrawal Date | 12/31/2020 |
Product Code |
MRA |
Docket Number | 07M-0287 |
Notice Date | 07/20/2007 |
Advisory Committee |
Orthopedic |
Expedited Review Granted? | No |
Combination Product | No |
Predetermined Change Control Plan Authorized | No |
Recalls | CDRH Recalls |
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 |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S007 S008 S009 S010 S016 S017 S018 S011 S012 S013 S014 S015 S019 S020 S021 |