Trinity Acetabular Hip System with HXLPE Liners 321.05.928
by Corin Ltd
Ref 321.05.928Model Trinity Polyethylene Liners
Active
CE MDD
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-05055196971820 05055196971820 | Date22 Sep 2026 | StatusActive |
| United States | GUDID listing GUDID | Number05055196971820 | Date17 Aug 2016 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Trinity Liner (HXLPE) Ø28mm Neutral 4mm EPW Taper Size 5 EUDAMEDTrinity Acetabular Hip System with HXLPE Liners GUDID
- Generic Name
- Non-constrained polyethylene acetabular liner
- Device Name
- Trinity HXLPE and ECiMa liners for use in Trinity Acetabular System
- Model / Ref / Catalog
- 321.05.928, Trinity Polyethylene Liners
- Primary DI / UDI-DI
- 05055196971820
- Basic UDI-DI
- B-05055196971820
- 510(k) Number
- FDA Product Code
- MEH, LZO
- EMDN Code
- P090803040101 Standard polyethylene hip prostheses inserts
- GMDN Term
- Non-constrained polyethylene acetabular liner
- Device Class
- Class III EUDAMEDClass II GUDID
- Regulation Number
- 888.3353
- EU market of registration
- France
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Ethylene Oxide
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class III | Class II |
Other devices from Corin Ltd
Properties
Other properties (18)
- Reusable: 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
- Manufacturing Date: No