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Viper Prime

by Medos International SARL 3 variants

Ref 286750131NModel VIPER PRIME Navigated Inserter Instruments

Viper Prime (286750131N) 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 0705034a0014763), cleared under FDA 510(k) K170937 on 14 Sep 2017 and listed in FDA GUDID since 22 Sep 2017 (UDI-DI 10705034507781), 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) K170937↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a0014763 Basic UDI-DI 10705034507781UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034507781 UDI-DI Date22 Sep 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK170937 Date14 Sep 2017IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0705034a0014763 registered 22 Oct 2026 Active
  • FDA 510(k) K170937 decided 14 Sep 2017 Active
  • FDA GUDID UDI-DI 10705034507781 listed 22 Sep 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K170937
  2. Listed FDA GUDID 10705034507781
  3. Registered EUDAMED 0705034a0014763

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  • Withdrawn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
Stereotactic surgery system probe, reusable
Device name
VIPER PRIME Navigated Inserter Drive Tube, Shaft, Adaptors, and Stylet
Model / Ref / Catalog
VIPER PRIME Navigated Inserter Instruments, 286750131N
Primary DI / UDI-DI
10705034507781
Basic UDI-DI
0705034a0014763
Direct marketing DI
10705034507781
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
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)