Conformity Stem

by United Orthopedic Corporation 79 variants

Ref 9110-6006

Conformity Stem (9110-6006) 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 2 Sep 2019 (UDI-DI 04711605585408), 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
European Union	CE/MDR EUDAMED	Number471987216TD-Ir-003F4 Basic UDI-DI 04711605585408UDI-DI	Date18 Feb 2025Registered	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK191056	Date3 Jan 2020Decided	StatusActive
United States	GUDID listing GUDID	Number04711605585408 UDI-DI	Date2 Sep 2019Listed	StatusListed GUDID: in commercial distribution
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 04711605585408
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 04711605585408 listed 2 Sep 2019 Listed

Timeline

4 dated events

8 Aug 2019 Cleared FDA 510(k) K183312
2 Sep 2019 Listed FDA GUDID 04711605585408
3 Jan 2020 Cleared FDA 510(k) K191056
18 Feb 2025 Registered EUDAMED 471987216TD-Ir-003F4

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Withdrawn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: Orthopaedic broach
Device name: United Hip and Knee Non-sterile Reusable Instruments
Model / Ref / Catalog: 9110-6006

Primary DI / UDI-DI: 04711605585408
Basic UDI-DI: 471987216TD-Ir-003F4
Direct marketing DI: 04711605585408
510(k) Number: K183312
K191056
FDA product code: JDI, KWY, MEH, LZO
EMDN code: L091202 Orthopaedic surgery files, reusable
GMDN term: Orthopaedic broach

Device class: Class I EUDAMED
Class II GUDID
Regulation number: 888.3350, 888.3390, 888.3353
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 SURGERY FILES, REUSABLE.

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)