CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
FDA premarket approval P010001/S021 · decided 2020-02-04
Approval details
- PMA number
- P010001
- Supplement
- S021
- 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
- 2019-12-23
- Decision date
- 2020-02-04
- Days to decision
- 43 days
- Decision code
- OK30
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Plochingen
- Statement
- Updates to the drying and rinsing stations prior to visual inspection of parts for cracks.
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