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CoCr Modular Head extra short E321.436

by Corin Ltd

Ref E321.436Model Trinity Cobalt Chrome Modular Heads

CoCr Modular Head extra short E321.436 is a device classified as Class III in the EU and Class II in the US made by Corin Ltd, registered in EUDAMED on 22 Sep 2026 (Basic UDI-DI B-05055343885109), cleared under FDA 510(k) K131647 on 27 Sep 2013 and listed in FDA GUDID since 17 Aug 2016 (UDI-DI 05055343885109), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K131647

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055343885109 Basic UDI-DI 05055343885109UDI-DIDate22 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055343885109 UDI-DI Date17 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK131647 Date27 Sep 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05055343885109 registered 22 Sep 2026 Active
  • FDA 510(k) K131647 decided 27 Sep 2013 Active
  • FDA GUDID UDI-DI 05055343885109 listed 17 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K131647
  2. Listed FDA GUDID 05055343885109
  3. Registered EUDAMED B-05055343885109

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Trinity CoCr Modular Head Ø36mm Extra-Short -8.0mm 12/14 Eurocone Taper EUDAMED
CoCr Modular Head extra short GUDID
Generic name
Metallic femoral head prosthesis
Device name
Trinity CoCr modular femoral heads for use in Trinity Acetabular System
Model / Ref / Catalog
E321.436, Trinity Cobalt Chrome Modular Heads
Primary DI / UDI-DI
05055343885109
Basic UDI-DI
B-05055343885109
510(k) Number
FDA product code
LZO, MEH
EMDN code
P090804050202 Metal femoral heads, total hip replacement
GMDN term
Metallic femoral head prosthesis
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3353
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 05055343885109: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Metallic femoral head prosthesis

Cleared under the same submission (K131647)

Similar devices in this category

Other devices filed under METAL FEMORAL HEADS, TOTAL HIP REPLACEMENT.

Other devices from Corin Ltd

See all devices from Corin Ltd →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)