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RONDO' Cannula for drill ø2.1mm

by Citieffe

Ref VP-92521Model CANNULAS

RONDO' Cannula for drill ø2.1mm (VP-92521) is a device classified as Class I in the EU and Class II in the US made by Citieffe, registered in EUDAMED on 8 Sep 2026 (Basic UDI-DI 803290962114BR), cleared under FDA 510(k) K113388 on 5 Jun 2012 and listed in FDA GUDID since 14 Nov 2023 (UDI-DI 08056711928685), 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 Number803290962114BR Basic UDI-DI 08056711928685UDI-DIDate8 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08056711928685 UDI-DI Date14 Nov 2023ListedStatusListed 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 803290962114BR registered 8 Sep 2026 Active
  • FDA 510(k) K113388 decided 5 Jun 2012 Active
  • FDA GUDID UDI-DI 08056711928685 listed 14 Nov 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K113388
  2. Listed FDA GUDID 08056711928685
  3. Registered EUDAMED 803290962114BR

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  • Withdrawn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
Strumenti Chirurgici (Ir) EUDAMED
Rondo' GUDID
Generic name
Surgical drill guide, reusable
Device name
Surgical Instruments (Ir)
Model / Ref / Catalog
CANNULAS, VP-92521, Cannula for drill ø2.1mm
Primary DI / UDI-DI
08056711928685
Basic UDI-DI
803290962114BR
Direct marketing DI
08056711928685
510(k) Number
FDA product code
HTY, HTN, HWC
EMDN code
L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
GMDN term
Surgical drill guide, reusable
Device class
Class I 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
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 2.1 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
CANNULAS
VP-92521
GUDID
Cannula for drill ø2.1mm
Device classEUDAMED
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.

Related devices

Category: Surgical drill guide, reusable

Cleared under the same submission (K113388)

and 8 more cleared under K113388

Similar devices in this category

Other devices filed under INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE.

Other devices from Citieffe

See all devices from Citieffe →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)