R3 DELTA CERAMIC HIP SYSTEM
FDA premarket approval P150030 · decided 2016-10-17
Approval details
- PMA number
- P150030
- Trade name
- R3 DELTA CERAMIC HIP SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2015-08-20
- Decision date
- 2016-10-17
- Days to decision
- 424 days
- Decision code
- APWD
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Approval for the R3TM delta Ceramic Acetabular System. This device is indicated for use in skeletally mature 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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