REFLECTION CERAMIC ACETABULAR SYSTEM
FDA premarket approval P030022 · decided 2004-12-17
Approval details
- PMA number
- P030022
- Trade name
- REFLECTION CERAMIC ACETABULAR SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2003-06-11
- Decision date
- 2004-12-17
- Days to decision
- 555 days
- Decision code
- APWD
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR THE REFLECTION CERAMIC ACETABULAR SYSTEM. THE DEVICE IS INDICATED FOR USE IN PATIENTS REQUIRING PRIMARY TOTAL HIP ARTHROPLASTY DUE TO NON-INFLAMMATORY ARTHRITIS (DEGENERATIVE JOINT DISEASE) SUCH AS OSTEOARTHRITIS, AVASCULAR NECROSIS, OR TRAUMATIC ARTHRITIS.
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