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Bipolar II™ 1503-4155

by United Orthopedic Corp.

Ref 1503-4155

Bipolar II™ 1503-4155 is a device classified as Class IIa in the EU and Class II in the US made by United Orthopedic Corp., registered in EUDAMED on 9 Feb 2026 (Basic UDI-DI B-04719872168683), cleared under FDA 510(k) K152439 on 7 Apr 2016 and listed in FDA GUDID since 19 May 2017 (UDI-DI 04719872168683), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K152439

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04719872168683 Basic UDI-DI 04719872168683UDI-DIDate9 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04719872168683 UDI-DI Date19 May 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK152439 Date7 Apr 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04719872168683 registered 9 Feb 2026 Active
  • FDA 510(k) K152439 decided 7 Apr 2016 Active
  • FDA GUDID UDI-DI 04719872168683 listed 19 May 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K152439
  2. Listed FDA GUDID 04719872168683
  3. Registered EUDAMED B-04719872168683

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
U2 Bipolar Implant EUDAMED
Bipolar II™ GUDID
Generic name
Acetabulum prosthesis trial, prefabricated, reusable
Device name
U2 Bipolar trial, Ø55mm, ID28mm
Model / Ref / Catalog
1503-4155
Primary DI / UDI-DI
04719872168683
Basic UDI-DI
B-04719872168683
510(k) Number
FDA product code
KWY
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Acetabulum prosthesis trial, prefabricated, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3390
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 II

Device class is stated on each registry's own scale: Class IIa 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: Acetabulum prosthesis trial, prefabricated, reusable

Cleared under the same submission (K152439)

and 8 more cleared under K152439

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from United Orthopedic Corp.

See all devices from United Orthopedic Corp. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)