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Viper 186715855

by Medos International Sàrl EUDAMEDGUDID

Active European Union

Ref 186715855Model VIPER Spine System Bone Screws

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a002065S Basic UDI-DIDate18 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034122762 UDI-DIDate24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

8 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-0706-2013 FDA Class II initiated 7 Nov 2012
    • Terminated Z-0705-2013 FDA Class II initiated 7 Nov 2012
    • Terminated Z-0708-2013 FDA Class II initiated 7 Nov 2012
    • Terminated Z-0712-2013 FDA Class II initiated 7 Nov 2012
    • Terminated Z-0709-2013 FDA Class II initiated 7 Nov 2012
    • Terminated Z-0707-2013 FDA Class II initiated 7 Nov 2012
    • Terminated Z-0710-2013 FDA Class II initiated 7 Nov 2012

    Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

    • Terminated Z-0713-2013 FDA Class II initiated 7 Nov 2012

    Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium. VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.

Specification

EUDAMED · GUDID

Trade Name
Viper System EUDAMED
Viper GUDID
Generic Name
Spinal bone screw, non-bioabsorbable
Model / Ref / Catalog
186715855, VIPER Spine System Bone Screws
Primary DI / UDI-DI
10705034122762
Basic UDI-DI
0705034a002065S
510(k) Number
FDA Product Code
MNI, MNH, NKB, KWQ, KWP
EMDN Code
P09070302 Thoracolumbosacral fixation systems
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3070, 888.3060, 888.3050
Market of Registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K101993)

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: 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
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No