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Conformity Stem

by United Orthopedic Corporation 8 variants

Ref 9110-5000-RC

Conformity Stem (9110-5000-RC) 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 10 Feb 2026 (Basic UDI-DI B-04719886901078), cleared under FDA 510(k) K242249 on 30 Aug 2024 and listed in FDA GUDID since 11 Sep 2024 (UDI-DI 04719886901078), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K242249

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04719886901078 Basic UDI-DI 04719886901078UDI-DIDate10 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04719886901078 UDI-DI Date11 Sep 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK242249 Date30 Aug 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04719886901078 registered 10 Feb 2026 Active
  • FDA 510(k) K242249 decided 30 Aug 2024 Active
  • FDA GUDID UDI-DI 04719886901078 listed 11 Sep 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K242249
  2. Listed FDA GUDID 04719886901078
  3. Registered EUDAMED B-04719886901078

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  • Withdrawn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

Generic name
Femoral stem prosthesis trial
Device name
Neck trial, standard offset, 125°
Model / Ref / Catalog
9110-5000-RC
Primary DI / UDI-DI
04719886901078
Basic UDI-DI
B-04719886901078
510(k) Number
FDA product code
LZO, MEH
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Femoral stem prosthesis trial
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3353
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.

Manufacturer details

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

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)