CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
FDA premarket approval P010001 · decided 2003-02-03
Approval details
- PMA number
- P010001
- Trade name
- CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Ceramtec GmbH
- Date received
- 2001-01-31
- Decision date
- 2003-02-03
- Days to decision
- 733 days
- Decision code
- APWD
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Plochingen
- Statement
- APPROVAL FOR THE CERAMIC TRANSCEND HIP ARTICULATION SYSTEM. THE 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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