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Knee Instruments 02.09.10.0106

by Medacta International

Ref 02.09.10.0106

Knee Instruments 02.09.10.0106 is a Class I device made by Medacta International, registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI 764014274KSR0180N00BX) and listed in FDA GUDID since 9 Jul 2020 (UDI-DI 07630040785679), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number764014274KSR0180N00BX Basic UDI-DI 07630040785679UDI-DIDate1 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630040785679 UDI-DI Date9 Jul 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 764014274KSR0180N00BX registered 1 Oct 2026 Active
  • FDA GUDID UDI-DI 07630040785679 listed 9 Jul 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07630040785679
  2. Registered EUDAMED 764014274KSR0180N00BX

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  • Withdrawn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
GMK Hinge - Extension Stem 15.5 drill bit guide EUDAMED
Knee Instruments GUDID
Generic name
Orthopaedic surgical procedure kit, non-medicated, reusable
Device name
Knee Drill guide
Model / reference
02.09.10.0106
Primary DI / UDI-DI
07630040785679
Basic UDI-DI
764014274KSR0180N00BX
Direct marketing DI
07630040785679
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

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY GUIDES, REUSABLE.

Other devices from Medacta International

See all devices from Medacta International →

Properties

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