- Device
- Transcend® Hip Articulation System
- Applicant
- Ceramtec GmbH
- PMA number
- P010001
- Supplement
- S028
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2024-10-16
- Decision code
- OK30
- Date received
- 2024-09-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of a coordinate measuring machine for dimensional inspection of the ceramic femoral heads and inserts of the TRANSCEND Hip Articulation System