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U2 Total Knee System

by United Orthopedic Corporation 689 variants

Ref 9323-3621

U2 Total Knee System (9323-3621) is a device classified as Class IIa in the EU and Class I in the US made by United Orthopedic Corp., registered in EUDAMED on 12 Feb 2026 (Basic UDI-DI B-04719886906738) and listed in FDA GUDID since 29 Apr 2025 (UDI-DI 04719886906738), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04719886906738 Basic UDI-DI 04719886906738UDI-DIDate12 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04719886906738 UDI-DI Date29 Apr 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04719886906738 registered 12 Feb 2026 Active
  • FDA GUDID UDI-DI 04719886906738 listed 29 Apr 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04719886906738
  2. Registered EUDAMED B-04719886906738

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  • Withdrawn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
Bone-resection orthopaedic reamer, reusable
Model / Ref / Catalog
9323-3621
Primary DI / UDI-DI
04719886906738
Basic UDI-DI
B-04719886906738
FDA product code
HTO
EMDN code
L091102 Orthopaedic prostheses reamers and burs, reusable
GMDN term
Bone-resection orthopaedic reamer, 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
France
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.

Manufacturer details

EUDAMED SRN
TW-MF-000009523
Authorised representative
mdi Europa GmbH DE-AR-000006218

Related devices

Category: Acetabular orthopaedic reamer

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE.

Other devices from United Orthopedic Corp.

See all devices from United Orthopedic Corp. →

Properties

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