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Trinity Acetabular Hip System 321.040

by Corin Ltd

Ref 321.040Model Trinity Bone Screws

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055196959163 Basic UDI-DI 05055196959163UDI-DIDate22 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055196959163 UDI-DI Date17 Aug 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Trinity Screw Ø6.5mm 40mm Length Cancellous Bone Screw EUDAMED
Trinity Acetabular Hip System GUDID
Generic Name
Orthopaedic bone screw, non-bioabsorbable, sterile
Device Name
Trinity cancellous bone screws for use in Trinity Acetabular System
Model / Ref / Catalog
321.040, Trinity Bone Screws
Primary DI / UDI-DI
05055196959163
Basic UDI-DI
B-05055196959163
510(k) Number
FDA Product Code
MEH, LZO, LWJ
EMDN Code
P09088007 Hip prostheses fixing screws
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, sterile
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3353, 888.3360
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilization Method
Radiation Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Related devices

Category: Orthopaedic bone screw, non-bioabsorbable, sterile

Cleared under the same submission (K093472)

Show all (12)

Other devices from Corin Ltd

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Properties

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

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