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Knee Instruments 02.12.10.1275

by Medacta International SA

Ref 02.12.10.1275

Knee Instruments 02.12.10.1275 is a device classified as Class IIa in the EU and Class I in the US made by Medacta International SA, registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI B-07630345715838) and listed in FDA GUDID since 20 Oct 2023 (UDI-DI 07630345715838), active as of 12 Nov 2026.

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

CE MDD

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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07630345715838 Basic UDI-DI 07630345715838UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630345715838 UDI-DI Date20 Oct 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-07630345715838 registered 3 Nov 2026 Active
  • FDA GUDID UDI-DI 07630345715838 listed 20 Oct 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07630345715838
  2. Registered EUDAMED B-07630345715838

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Trial Tibial Insert FLEX S6R - 20 mm EUDAMED
Knee Instruments GUDID
Generic name
Orthopaedic surgical procedure kit, non-medicated, reusable
Device name
Knee Trial Tibial Insert Plastic
Model / reference
02.12.10.1275
Primary DI / UDI-DI
07630345715838
Basic UDI-DI
B-07630345715838
FDA product code
LXH
EMDN code
V06010102 Knee prostheses testing devices
GMDN term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
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 surgical procedure kit, non-medicated, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES TESTING DEVICES.

Other devices from Medacta International SA

See all devices from Medacta International SA →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)