DURALOC OPTION CERAMIC HIP SYSTEM
FDA premarket approval P040023/S012 · decided 2008-12-30
Approval details
- PMA number
- P040023
- Supplement
- S012
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DURALOC OPTION CERAMIC HIP SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- DePuy Orthopaedics, Inc.
- Date received
- 2008-11-18
- Decision date
- 2008-12-30
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT CERAMTEC AG, MARKTREDWITZ, GERMANY, FOR MANUFACTURING OF THE BIOLOX FORTE CERAMIC HEADS AND LINERS.
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| ACTIS Duofix Hip Prosthesis (K202472) | DePuy Orthopaedics, Inc. | 2020-10-21 |
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