Conformity Stem

by United Orthopedic Corporation 79 variants

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

Ref 9110-8301

Conformity Stem (9110-8301) 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) K191056 on 3 Jan 2020 (1 earlier submission) and listed in FDA GUDID since 11 Sep 2025 (UDI-DI 04719872145332), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K191056

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing GUDID	Number04719872145332 UDI-DI	Date11 Sep 2025Listed	StatusListed GUDID: in commercial distribution
European Union	CE/MDR EUDAMED	Number471987216TD-Ir-003F4 Basic UDI-DI 04719872145332UDI-DI	Date18 Feb 2025Registered	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK191056	Date3 Jan 2020Decided	StatusActive
United States	FDA 510(k) GUDID from GUDID	NumberK183312	Date8 Aug 2019Issued	StatusActive

Official records

EUDAMED public site Basic UDI-DI 471987216TD-Ir-003F4 — open Devices and search for it
AccessGUDID record UDI-DI 04719872145332
FDA 510(k) database 510(k) number K191056
FDA 510(k) database 510(k) number K183312

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 471987216TD-Ir-003F4 registered 18 Feb 2025 Active
FDA 510(k) K191056 decided 3 Jan 2020 Active· +1 more in the status table
FDA GUDID UDI-DI 04719872145332 listed 11 Sep 2025 Listed

Timeline

4 dated events

8 Aug 2019 Cleared FDA 510(k) K183312
3 Jan 2020 Cleared FDA 510(k) K191056
18 Feb 2025 Registered EUDAMED 471987216TD-Ir-003F4
11 Sep 2025 Listed FDA GUDID 04719872145332

Coverage

2 jurisdictions

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Withdrawn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: 9110-8301

Primary DI / UDI-DI: 04719872145332
Basic UDI-DI: 471987216TD-Ir-003F4
Direct marketing DI: 04719872145332
510(k) Number: K183312
K191056
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

Field	EUDAMED	GUDID
Device class	EUDAMED 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)