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EXPEDIUM and VIPER 2 SPINE SYSTEM

by Medos International SARL EUDAMED510(k)GUDID

Active United States and European Union

Ref 286720100, 196789300S, 196789300, 196789200, 196789600Model Viper Reusable Instruments for Insertion and Extraction, VIPER Spine System Rods

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a001365W Basic UDI-DIDate24 Dec 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK160904 Date1 Jul 2016IssuedStatusActive
United StatesGUDID listing GUDID Number10705034214214 UDI-DIDate24 Sep 2015ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

1 recall · FDA

    • Terminated Z-1674-2015 FDA Class II initiated 21 Apr 2015

    Device does not mate as intended.

Specification

EUDAMED · 510(k) · GUDID

Trade Name
EXPEDIUM and VIPER 2 SPINE SYSTEM EUDAMED
Expedium Viper GUDID
Generic Name
Bone-screw internal spinal fixation system rod
Orthopaedic implant driver
Device Name
VIPER Spine System Straight Rods Straight Rod, Pre-Bent Rod, Pre-Kyphosed, Pre-Lordosed
Model / Ref / Catalog
Viper Reusable Instruments for Insertion and Extraction, 286720100, 196789300, 196789600, 196789200, VIPER Spine System Rods, 196789300S
Primary DI / UDI-DI
10705034214214, 10705034295251, 10705034295282, 10705034295244, 10705034394602
Basic UDI-DI
0705034a001365W, 0705034a002105H
Direct Marketing DI
10705034214214
510(k) Number
FDA Product Code
OSH, MNH, MNI, KWQ, KWP, NKB, HWR
EMDN Code
L091001, P09070302
GMDN Term
Bone-screw internal spinal fixation system rod
Orthopaedic implant driver
Device Class
Class I EUDAMEDGUDID
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3070, 888.3060, 888.3050, 888.4540
Market of Registration
Belgium
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
Class IIb
GUDID
Class I
Class II
SterileEUDAMED
No
Yes
GUDID
No

Manufacturer details

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

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

  • Sterile NoEUDAMEDGUDIDYesEUDAMED
  • Single Use YesGUDIDNoGUDID
  • Implantable NoEUDAMEDGUDIDYesEUDAMEDGUDID
  • Reusable YesEUDAMEDNoEUDAMED
  • Sutures
  • CMR Substance NoEUDAMEDYesEUDAMED
  • Prescription Use
  • Premarket Exempt NoGUDIDYesGUDID
  • Lot / Batch Number

Other properties (16)

  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No