TaperFit Cemented Hip System E922.132
by Corin Ltd
Ref E922.132Model Trinity Acetabular System Instrument Set
Active
CE MDD
Valid until
Not listed
FDA recalls
None ongoingDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-05055196969957 05055196969957 | Date14 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number05055196969957 | Date17 Aug 2016 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
-
- Terminated Z-1667-2022
Some of the devices did not pass fatigue testing.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Ø32mm/0/Medium Modular Head Trial EUDAMEDTaperFit Cemented Hip System GUDID
- Generic Name
- Femoral head prosthesis trial
- Model / Ref / Catalog
- E922.132, Trinity Acetabular System Instrument Set
- Primary DI / UDI-DI
- 05055196969957
- Basic UDI-DI
- B-05055196969957
- 510(k) Number
- FDA Product Code
- JDI, JDG
- EMDN Code
- L0999 Orthopaedic and traumatological surgery instruments, reusable - other
- GMDN Term
- Femoral head prosthesis trial
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 888.3350, 888.3360
- EU market of registration
- France
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Other devices from Corin Ltd
Properties
Other properties (21)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No