NOVATION CERAMIC ARTICULATION HIP SYSTEM
FDA premarket approval P050039 · decided 2007-07-05
Approval details
- PMA number
- P050039
- Trade name
- NOVATION CERAMIC ARTICULATION HIP SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Exactech, Inc.
- Date received
- 2005-10-27
- Decision date
- 2007-07-05
- Days to decision
- 616 days
- Decision code
- APWD
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Gainesville, FL
- 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.
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510(k) clearances by this applicant
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|---|---|---|
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