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2307-96-000

by Depuy (Ireland)

Ref 2307-96-000Model Orthopaedic Prostheses Implantation Instrument, Single-Use

2307-96-000 (230796000) is a device classified as Class IIa in the EU and Class I in the US made by Depuy (Ireland), registered in EUDAMED on 2 Sep 2026 (Basic UDI-DI 0603295a005418V) and listed in FDA GUDID since 24 Sep 2018 (UDI-DI 10603295116608), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0603295a005418V Basic UDI-DI 10603295116608UDI-DIDate2 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10603295116608 UDI-DI Date24 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0603295a005418V registered 2 Sep 2026 Active
  • FDA GUDID UDI-DI 10603295116608 listed 24 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10603295116608
  2. Registered EUDAMED 0603295a005418V

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  • Withdrawn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
Delta Xtend
Generic name
Orthopaedic prosthesis implantation positioning instrument, single-use
Device name
Orthopaedic Prostheses Implantation Instrument, Single-Use
Model / Ref / Catalog
2307-96-000, Orthopaedic Prostheses Implantation Instrument, Single-Use, 230796000
Primary DI / UDI-DI
10603295116608
Basic UDI-DI
0603295a005418V
FDA product code
LXH
EMDN code
P091399 Orthopaedic implant instruments, single-use - other
GMDN term
Orthopaedic prosthesis implantation positioning instrument, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, single-use

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Depuy (Ireland)

See all devices from Depuy (Ireland) →

Properties

  • Sterilise before use
  • Premarket exempt
Other properties (23, all answered No)