Skip to content

Cellbrick knee spacer

by United Orthopedic Corporation 6 variants

Ref 9909-7414

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

CE MDR 510(k)

Valid until

Not listed

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) K243024↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), 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 04719886901757UDI-DIDate18 Feb 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK243024 Date20 Dec 2024IssuedStatusActive
United StatesGUDID listing GUDID Number04719886901757 UDI-DI Date8 Apr 2024ListedStatusListed 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  • Withdrawn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
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Generic Name
Surgical implant template, reusable
Device Name
United Hip and Knee Non-sterile Reusable Instruments
Model / Ref / Catalog
9909-7414
Primary DI / UDI-DI
04719886901757
Basic UDI-DI
471987216TD-Ir-003F4
Direct Marketing DI
04719886901757
FDA Product Code
HWT
EMDN Code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN Term
Surgical implant template, reusable
Device Class
Class I
Regulation Number
888.4800
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

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
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • 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
  • Serial Number: No
  • Expiration Date: No