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Universal Navigation Viper System

by Medos International SARL 11 variants

Part of a family of 32 devices: see the family page

Ref 286715800NModel Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems - Orthopaedic Surgery Instruments

Universal Navigation Viper System (286715800N) is a device classified as Class IIa in the EU and Class II in the US made by Medos International SARL, registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 0705034a001505Q), cleared under FDA 510(k) K140927 on 24 Oct 2014 (1 earlier submission) and listed in FDA GUDID since 30 Jun 2016 (UDI-DI 10705034388519), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K140927

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a001505Q Basic UDI-DI 10705034388519UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034388519 UDI-DI Date30 Jun 2016ListedStatusListed 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 0705034a001505Q registered 22 Oct 2026 Active
  • FDA 510(k) K140927 decided 24 Oct 2014 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10705034388519 listed 30 Jun 2016 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K120867
  2. Cleared FDA 510(k) K140927
  3. Listed FDA GUDID 10705034388519
  4. Registered EUDAMED 0705034a001505Q

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  • Withdrawn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 Viper System EUDAMED
Viper GUDID
Generic name
Stereotactic surgery system probe, reusable
Device name
Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems - Probes, awls, drivers
Model / Ref / Catalog
Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems - Orthopaedic Surgery Instruments, 286715800N
Primary DI / UDI-DI
10705034388519
Basic UDI-DI
0705034a001505Q
Direct marketing DI
10705034388519
510(k) Number
FDA product code
OLO
EMDN code
Z12130480 Stereotactic orthopaedic surgery instruments - hardware accessories
GMDN term
Stereotactic surgery system probe, reusable
Device class
Class IIa 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 IIa
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
CH-MF-000014268
Authorised representative
DePuy Ireland UC IE-AR-000009328

Related devices

Category: Multi-purpose stereotactic surgery system

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
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)