Trinity Acetabular Hip System 321.02.328
by Corin Ltd
Trinity Acetabular Hip System 321.02.328 is a Class II device made by Corin Ltd, cleared under FDA 510(k) K093472 on 23 Nov 2010 and listed in FDA GUDID since 17 Aug 2016 (UDI-DI 05055196933651), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05055196933651 | Date17 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK093472 | Date23 Nov 2010 | StatusActive |
Official records
- AccessGUDID record 05055196933651
- FDA 510(k) database K093472
Across registries
- FDA 510(k) K093472 decided 23 Nov 2010 Active
- FDA GUDID UDI-DI 05055196933651 listed 17 Aug 2016 Listed
Recalls
-
- Terminated Z-2604-2021
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
Timeline
- Cleared FDA 510(k) K093472
- Listed FDA GUDID 05055196933651
- Recall initiated FDA recalls Z-2604-2021
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Trinity Acetabular Hip System
- Generic name
- Non-constrained polyethylene acetabular liner
- Model / Ref / Catalog
- 321.02.328
- Primary DI / UDI-DI
- 05055196933651
- 510(k) Number
- FDA product code
- LZO, MEH, LWJ
- GMDN term
- Non-constrained polyethylene acetabular liner
- Device class
- Class II
- Regulation number
- 888.3353, 888.3360
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Radiation Sterilization
Similar devices in this category
Other devices filed under Non-constrained polyethylene acetabular liner.
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- Trilogy® Longevity® 6305-58-22 00-6305-058-22 by Zimmer, Inc.
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- U2 Acetabular Components 1403-1152 by UNITED ORTHOPEDIC CORP.
- CSF Plus CLP75® Highly Cross Linked UHMWPE Liner 10° Hooded 28mm I/D for 60mm O/D Cup 151-60-28 by JRI Orthopaedics Ltd
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