Ceramic TRANSCEND® Hip Articulation System
FDA premarket approval P010001/S029 · decided 2025-04-23
Approval details
- PMA number
- P010001
- Supplement
- S029
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Ceramic TRANSCEND® Hip Articulation System
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Ceramtec GmbH
- Date received
- 2025-03-25
- Decision date
- 2025-04-23
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Plochingen
- Statement
- the addition of a grinding machine for the manufacturing of the ceramic femoral heads within the TRANSCEND® Hip Articulation System
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