- Device
- Trident Acetabular System: Trident Alumina Inserts
- Applicant
- Howmedica Osteonics Corp.
- PMA number
- P000013
- Supplement
- S020
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2022-04-01
- Decision code
- APPR
- Date received
- 2022-03-03
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updating the instructions for use (IFU) for the Trident Acetabular System: Trident Alumina Inserts because of European Union (EU) requirements.