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U2 Bipolar Implant

by United Orthopedic Corporation 5 variants

Ref 9203-5028, 1503-4341-RB, 1503-4149-RD, 1503-4158, 1503-4154

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

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number471987216TD-Ir-003F4 Basic UDI-DI Date18 Feb 2025RegisteredStatusActive
European UnionCE/MDR EUDAMED Number471987216TD-Ir-003F4 Basic UDI-DI Date18 Feb 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04719872173526 UDI-DI Date8 Feb 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · FDA

    • Terminated Z-1383-2013 FDA Class II initiated 20 Feb 2013

    The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
U2 Bipolar Implant EUDAMEDGUDID
Bipolar II™ GUDID
Generic Name
Acetabulum prosthesis trial, prefabricated, reusable
Orthopaedic inorganic implant inserter/extractor, reusable
Device Name
United Hip and Knee Non-sterile Reusable Instruments
U2 Bipolar trial, Ø54mm, ID28mm
Model / Ref / Catalog
9203-5028, 1503-4158, 1503-4149-RD, 1503-4341-RB, 1503-4154
Primary DI / UDI-DI
04719872173526, 04719886893588, 04719872140320, 04711605581929, 04719872168676
Basic UDI-DI
471987216TD-Ir-003F4, B-04711605581929, B-04719872140320, B-04719886893588, B-04719872168676
Direct Marketing DI
04719872173526
510(k) Number
FDA Product Code
KWY, HWB
EMDN Code
L091101, L091199
GMDN Term
Acetabulum prosthesis trial, prefabricated, reusable
Orthopaedic inorganic implant inserter/extractor, reusable
Device Class
Class I EUDAMEDGUDID
Class IIa EUDAMED
Class II GUDID
Regulation Number
888.3390, 888.4540
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
Class IIa
GUDID
Class I
Class II

Manufacturer details

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

Other devices from United Orthopedic Corp.

See all devices from United Orthopedic Corp. →

Properties

  • Reusable
  • Prescription Use
  • Premarket Exempt NoGUDIDYesGUDID
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No