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Conformity Stem

by United Orthopedic Corporation 79 variants

Part of a family of 1,038 devices: see the family page

Ref 9110-8315

Conformity Stem (9110-8315) is a device classified as Class I in the EU and Class II in the US made by United Orthopedic Corp., registered in EUDAMED on 18 Feb 2025 (Basic UDI-DI 471987216TD-Ir-003F4), cleared under FDA 510(k) K243466 on 6 Jan 2025 (3 earlier submissions) and listed in FDA GUDID since 24 Apr 2025 (UDI-DI 04719886904277), active as of 24 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K243466

+3 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04719886904277 UDI-DI Date24 Apr 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number471987216TD-Ir-003F4 Basic UDI-DI 04719886904277UDI-DIDate18 Feb 2025RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK243466 Date6 Jan 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 471987216TD-Ir-003F4 registered 18 Feb 2025 Active
  • FDA 510(k) K243466 decided 6 Jan 2025 Active· +3 more in the status table
  • FDA GUDID UDI-DI 04719886904277 listed 24 Apr 2025 Listed

Timeline

6 dated events

  1. Cleared FDA 510(k) K183312
  2. Cleared FDA 510(k) K191056
  3. Cleared FDA 510(k) K242249
  4. Cleared FDA 510(k) K243466
  5. Registered EUDAMED 471987216TD-Ir-003F4
  6. Listed FDA GUDID 04719886904277

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Instrument tray, reusable
Device name
United Hip and Knee Non-sterile Reusable Instruments
Model / Ref / Catalog
9110-8315
Primary DI / UDI-DI
04719886904277
Basic UDI-DI
471987216TD-Ir-003F4
Direct marketing DI
04719886904277
510(k) Number
FDA product code
LZO, MEH, JDI, KWY
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Instrument tray, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3353, 888.3350, 888.3390
EU registration type
Standard device
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 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
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)