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RONDO' Washer ø16mm

by Citieffe

Ref VT-65000Model WASHERS

RONDO' Washer ø16mm (VT-65000) is a device classified as Class IIb in the EU and Class II in the US made by Citieffe, registered in EUDAMED on 8 Sep 2026 (Basic UDI-DI 803290962022BK), cleared under FDA 510(k) K113388 on 5 Jun 2012 and listed in FDA GUDID since 21 Oct 2015 (UDI-DI 08032909629565), 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) K113388

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number803290962022BK Basic UDI-DI 08032909629565UDI-DIDate8 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08032909629565 UDI-DI Date21 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK113388 Date5 Jun 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 803290962022BK registered 8 Sep 2026 Active
  • FDA 510(k) K113388 decided 5 Jun 2012 Active
  • FDA GUDID UDI-DI 08032909629565 listed 21 Oct 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K113388
  2. Listed FDA GUDID 08032909629565
  3. Registered EUDAMED 803290962022BK

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  • Withdrawn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

Trade name
Rondo'
Generic name
Orthopaedic bone washer, sterile
Model / Ref / Catalog
WASHERS, VT-65000, Washer ø16mm
Description
ø16mm washer for ø6.5-7.5mm screw. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
Primary DI / UDI-DI
08032909629565
Basic UDI-DI
803290962022BK
510(k) Number
FDA product code
HTY, HTN, HWC
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
Orthopaedic bone washer, sterile
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040, 888.3030
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 16 Millimeter

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
WASHERS
VT-65000
GUDID
Washer ø16mm
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic bone washer, sterile

Cleared under the same submission (K113388)

and 8 more cleared under K113388

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES.

Other devices from Citieffe

See all devices from Citieffe →

Properties

  • Supplied sterile
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)