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Knee Instruments 11.00005

by Medacta International

Ref 11.00005Model Knee Single use patella kit

Knee Instruments 11.00005 is a device classified as Class IIa in the EU and Class I in the US made by Medacta International, registered in EUDAMED on 15 Jul 2026 (Basic UDI-DI 764014274KSD0542R004X) and listed in FDA GUDID since 31 Mar 2021 (UDI-DI 07630030877384), 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 Number764014274KSD0542R004X Basic UDI-DI 07630030877384UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630030877384 UDI-DI Date31 Mar 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 764014274KSD0542R004X registered 15 Jul 2026 Active
  • FDA GUDID UDI-DI 07630030877384 listed 31 Mar 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07630030877384
  2. Registered EUDAMED 764014274KSD0542R004X

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  • Withdrawn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
Resurfacing patella instrument set EUDAMED
Knee Instruments GUDID
Generic name
Orthopaedic surgical procedure kit, non-medicated, reusable
Model / reference
11.00005, Knee Single use patella kit
Primary DI / UDI-DI
07630030877384
Basic UDI-DI
764014274KSD0542R004X
FDA product code
LXH
EMDN code
P091399 Orthopaedic implant instruments, single-use - other
GMDN term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

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 surgical procedure kit, non-medicated, reusable

Similar devices in this category

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

Other devices from Medacta International

See all devices from Medacta International →

Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)