PINNACLE COMPLETE ACETABULAR HIP SYSTEM
FDA premarket approval P090002/S007 · decided 2012-12-21
Approval details
- PMA number
- P090002
- Supplement
- S007
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PINNACLE COMPLETE ACETABULAR HIP SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, ceramic-on-metal articulation
- Applicant
- DePuy Orthopaedics, Inc.
- Date received
- 2012-11-28
- Decision date
- 2012-12-21
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- OVO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR CHANGES TO THE PRODUCT LABELING/ INFORMATION FOR USE FOR THE DEVICE.
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510(k) clearances by this applicant
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| 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 |