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KneeAlign 2 401573

by Orthalign, Inc.

Ref 401573

KneeAlign 2 401573 is a device classified as Class I in the EU and Class II in the US made by Orthalign, Inc., registered in EUDAMED on 20 Nov 2023 (Basic UDI-DI B-00858704006176) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00858704006176), active as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00858704006176 Basic UDI-DI 00858704006176UDI-DIDate20 Nov 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00858704006176 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00858704006176 registered 20 Nov 2023 Active
  • FDA GUDID UDI-DI 00858704006176 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00858704006176
  2. Registered EUDAMED B-00858704006176

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  • Withdrawn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
KneeAlign 2
Generic name
Orthopaedic surgical procedure kit, non-medicated, reusable
Model / Ref / Catalog
401573
Primary DI / UDI-DI
00858704006176
Basic UDI-DI
B-00858704006176
FDA product code
OLO
EMDN code
L0908 Orthopaedic and traumatological traction instruments, reusable
GMDN term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4560
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 I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II 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 AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE.

Other devices from Orthalign, Inc.

  • Lantern ASC 503000

    Class II

  • Lantern ASC 407001-02

    Class II

  • Lantern 405310 Open recall

    Class II

  • Lantern ASC 407001-01

    Class II

See all devices from Orthalign, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (19, all answered No)