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Attune 2546-00-001

by Depuy (Ireland)

Ref 2546-00-001

Attune 2546-00-001 (254600001) is a Class I device made by Depuy (Ireland), registered in EUDAMED on 13 May 2026 (Basic UDI-DI 0603295a000388F) and listed in FDA GUDID since 5 Dec 2016 (UDI-DI 10603295438670), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0603295a000388F Basic UDI-DI 10603295438670UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10603295438670 UDI-DI Date5 Dec 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0603295a000388F registered 13 May 2026 Active
  • FDA GUDID UDI-DI 10603295438670 listed 5 Dec 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10603295438670
  2. Registered EUDAMED 0603295a000388F

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Attune Knee System EUDAMED
Attune GUDID
Generic name
Surgical instrument/implant depth limiter, reusable
Model / Ref / Catalog
2546-00-001, 254600001
Primary DI / UDI-DI
10603295438670
Basic UDI-DI
0603295a000388F
Direct marketing DI
10603295438670
FDA product code
HTJ
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Surgical instrument/implant depth limiter, reusable
Device class
Class I
Regulation number
888.4300
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical instrument/implant depth limiter, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Depuy (Ireland)

See all devices from Depuy (Ireland) →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)