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Trinity Acetabular Hip System 921.205

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 Number05055343868874 UDI-DI Date21 Aug 2018ListedStatusListed 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  • Withdrawn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
Fluted surgical drill bit, reusable
Model / Ref / Catalog
921.205
Primary DI / UDI-DI
05055343868874
510(k) Number
FDA Product Code
LWJ, LZO, MEH
GMDN Term
Fluted surgical drill bit, reusable
Device Class
Class II
Regulation Number
888.3360, 888.3353
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Fluted surgical drill bit, reusable

Cleared under the same submission (K093472)

Show all (12)

Other devices from Corin Ltd

See all devices from Corin Ltd →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: 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