DURALOC OPTION CERAMIC HIP SYSTEM
FDA premarket approval P040023/S015 · decided 2010-06-04
Approval details
- PMA number
- P040023
- Supplement
- S015
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process 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
- 2009-12-02
- Decision date
- 2010-06-04
- Days to decision
- 184 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR A MANUFACTURING PROCESS CHANGE TO THE GRIT BLAST OPERATION FOR THE POROUS COATED SUMMIT HIP FEMORAL PROSTHESIS.
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510(k) clearances by this applicant
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| DELTA XTEND Reverse Shoulder System (K210167) | DePuy Orthopaedics, Inc. | 2021-02-19 |
| DePuy Corail AMT Hip Prosthesis (K203167) | DePuy Orthopaedics, Inc. | 2020-11-19 |
| ACTIS Duofix Hip Prosthesis (K202472) | DePuy Orthopaedics, Inc. | 2020-10-21 |
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| TRUMATCH Personalized Solutions (K193540) | DePuy Orthopaedics, Inc. | 2020-06-16 |