TRILOGY AB ACETABULAR SYSTEM
FDA premarket approval P040048/S008 · decided 2009-08-27
Approval details
- PMA number
- P040048
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TRILOGY AB ACETABULAR SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Zimmer, Inc.
- Date received
- 2009-05-11
- Decision date
- 2009-08-27
- Days to decision
- 108 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN MARKTREDWITZ, GERMANY.
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| G7® Revision Acetabular System (K252623) | Zimmer, Inc. | 2026-02-04 |