- Device
- CERAMAX CERAMIC HIP SYSTEM
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P070026
- Supplement
- S122
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2025-08-01
- Decision code
- OK30
- Date received
- 2025-07-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to reduce the inspection tier for the sponsor’s suppliers that have demonstrated successful quality history through the receiving inspection at the Cork facility