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286755005N

by Medos International Sàrl

Ref 286755005NModel Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems - Stereotactic Orthopaedic Surgery Instruments

286755005N is an orthopaedic implant-instrument extension adaptor (EU MDR Class I; FDA Class II; FDA product code OLO, Orthopedic stereotaxic instrument) made by Medos International Sàrl, registered in EUDAMED on 24 Dec 2025 (Basic UDI-DI 0705034a001515S), cleared under FDA 510(k) K140927 on 24 Oct 2014 and listed in FDA GUDID since 5 Jul 2017 (UDI-DI 10705034515809), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K140927

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a001515S Basic UDI-DI 10705034515809UDI-DIDate24 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034515809 UDI-DI Date5 Jul 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK140927 Date24 Oct 2014IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0705034a001515S registered 24 Dec 2025 Active
  • FDA 510(k) K140927 decided 24 Oct 2014 Active
  • FDA GUDID UDI-DI 10705034515809 listed 5 Jul 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K140927
  2. Listed FDA GUDID 10705034515809
  3. Registered EUDAMED 0705034a001515S

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  • Withdrawn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
Universal Navigation
Generic name
Orthopaedic implant-instrument extension adaptor, reusable
Device name
Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems - Handles, Adaptors, and Clamps
Model / Ref / Catalog
286755005N, Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems - Stereotactic Orthopaedic Surgery Instruments
Primary DI / UDI-DI
10705034515809
Basic UDI-DI
0705034a001515S
Direct marketing DI
10705034515809
510(k) Number
FDA product code
OLO
EMDN code
Z12130480 Stereotactic orthopaedic surgery instruments - hardware accessories
GMDN term
Orthopaedic implant-instrument extension adaptor, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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

Cleared under the same submission (K140927)

Similar devices in this category

Other devices filed under STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)