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Trinity Acetabular Hip System 321.04.032

by Corin Ltd

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05055196933521 UDI-DI Date17 Aug 2016ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-2604-2021 FDA Class II initiated 28 Jul 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.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Trinity Acetabular Hip System
Generic Name
Non-constrained polyethylene acetabular liner
Model / Ref / Catalog
321.04.032
Primary DI / UDI-DI
05055196933521
510(k) Number
FDA Product Code
LWJ, MEH, LZO
GMDN Term
Non-constrained polyethylene acetabular liner
Device Class
Class II
Regulation Number
888.3360, 888.3353
GUDID distribution status
In Commercial Distribution
Sterilization Method
Radiation Sterilization

Related devices

Category: Non-constrained polyethylene acetabular liner

Cleared under the same submission (K093472)

Show all (12)

Other devices from Corin Ltd

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No