Skip to content

Knee Instruments 02.07.10.2015

by Medacta International SA

Ref 02.07.10.2015

Knee Instruments 02.07.10.2015 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 2 Nov 2026 (Basic UDI-DI B-07630040785235) and listed in FDA GUDID since 27 Apr 2021 (UDI-DI 07630040785235), 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-07630040785235 Basic UDI-DI 07630040785235UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630040785235 UDI-DI Date27 Apr 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-07630040785235 registered 2 Nov 2026 Active
  • FDA GUDID UDI-DI 07630040785235 listed 27 Apr 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07630040785235
  2. Registered EUDAMED B-07630040785235

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  • Withdrawn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
Drill bit 8 mm EUDAMED
Knee Instruments GUDID
Generic name
Orthopaedic surgical procedure kit, non-medicated, reusable
Device name
Knee Drill bit / Reamer
Model / reference
02.07.10.2015
Primary DI / UDI-DI
07630040785235
Basic UDI-DI
B-07630040785235
FDA product code
LXH
EMDN code
Z12130503, Z12130599
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 · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 07630040785235: EUDAMED states No, FDA GUDID states Yes.

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 SURGICAL DRILLS.

Other devices from Medacta International SA

See all devices from Medacta International SA →

Properties

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