R3 Delta Ceramic Hip System, Reflection Ceramic Hip System
FDA premarket approval P150030/S021 · decided 2022-05-17
Approval details
- PMA number
- P150030
- Supplement
- S021
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- R3 Delta Ceramic Hip System, Reflection Ceramic Hip System
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2022-04-29
- Decision date
- 2022-05-17
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Addition of a new forging press and relocation of the trim operation step for the forging process of ANTHOLOGY stems.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.