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UCP Stem

by United Orthopedic Corporation 29 variants

Ref 9107-6431

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number471987216TD-Ir-003F4 Basic UDI-DI 04719872167648UDI-DIDate18 Feb 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04719872167648 UDI-DI Date15 May 2017ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Orthopaedic broach
Device Name
United Hip and Knee Non-sterile Reusable Instruments
Model / Ref / Catalog
9107-6431
Primary DI / UDI-DI
04719872167648
Basic UDI-DI
471987216TD-Ir-003F4
Direct Marketing DI
04719872167648
510(k) Number
FDA Product Code
LZO, KWY, JDI, LWJ
EMDN Code
L091202 Orthopaedic surgery files, reusable
GMDN Term
Orthopaedic broach
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
888.3353, 888.3390, 888.3350, 888.3360
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

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

Other devices from United Orthopedic Corp.

See all devices from United Orthopedic Corp. →

Properties

  • Reusable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No