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Knee Instruments 02.18.10.0312

by Medacta International

Ref 02.18.10.0312

Knee Instruments 02.18.10.0312 is a Class I device made by Medacta International, registered in EUDAMED on 15 Jun 2026 (Basic UDI-DI 764014274KSR0261N00BV) and listed in FDA GUDID since 24 Nov 2021 (UDI-DI 07630971247765), 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 Number764014274KSR0261N00BV Basic UDI-DI 07630971247765UDI-DIDate15 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630971247765 UDI-DI Date24 Nov 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 764014274KSR0261N00BV registered 15 Jun 2026 Active
  • FDA GUDID UDI-DI 07630971247765 listed 24 Nov 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07630971247765
  2. Registered EUDAMED 764014274KSR0261N00BV

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  • Withdrawn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
Femoral gauge S2 Left - multiple posterior shims EUDAMED
Knee Instruments GUDID
Generic name
Orthopaedic surgical procedure kit, non-medicated, reusable
Device name
Knee Pin positioner
Model / reference
02.18.10.0312
Primary DI / UDI-DI
07630971247765
Basic UDI-DI
764014274KSR0261N00BV
Direct marketing DI
07630971247765
FDA product code
LXH
EMDN code
L0922 Orthopaedic surgery guides, reusable
GMDN term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic surgical procedure kit, non-medicated, reusable

Other devices from Medacta International

See all devices from Medacta International →

Properties

  • Sterilise before use
  • Single use
  • Reusable
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)