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OrthAlign Plus

by OrthAlign, Inc 33 variants

Ref 403001-07Model 403001

OrthAlign Plus (403001-07) is an orthopaedic stereotactic surgery system (EU MDD Class I; FDA Class II; FDA product code OLO, Orthopedic Stereotaxic Instrument) made by Orthalign, Inc., registered in EUDAMED on 19 Oct 2023 (Basic UDI-DI B-00810832031352) and listed in FDA GUDID since 29 Jun 2021 (UDI-DI 00810832031352), 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-00810832031352 Basic UDI-DI 00810832031352UDI-DIDate19 Oct 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00810832031352 UDI-DI Date29 Jun 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00810832031352 registered 19 Oct 2023 Active
  • FDA GUDID UDI-DI 00810832031352 listed 29 Jun 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810832031352
  2. Registered EUDAMED B-00810832031352

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  • Withdrawn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

Generic name
Orthopaedic stereotactic surgery system
Device name
OrthAlign Plus Unit
Model / Ref / Catalog
403001, 403001-07
Primary DI / UDI-DI
00810832031352
Basic UDI-DI
B-00810832031352
FDA product code
OLO
EMDN code
V0380 Devices with measuring functions - accessories
GMDN term
Orthopaedic stereotactic surgery system
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

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.

Manufacturer details

EUDAMED SRN
US-MF-000027362
Authorised representative
MDSS GmbH DE-AR-000005430

Similar devices in this category

Other devices filed under DEVICES WITH MEASURING FUNCTIONS - ACCESSORIES.

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

  • Supplied sterile
  • Single use
  • Measuring function
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)