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Viper 2 System

by Medos International SARL EUDAMEDGUDID

Active European Union and United States

Ref 186715780S, 186715550S, 186715835S, 186715770S, 186715620S, 186717540S, 186715555S, 186715435S, 186717635S, 186715840S, 186715545S, 186717640S, 186715440S, 186715760S, 286735255, 186715660S, 186715730S, 186715535S, 286735252, 186715035S, 186789060S, 286705014, 186788080S, 286725405, 186717650S, 186715845S, 186789090S, 186789140S, 186789150S, 186789080S, 186787150S, 186788055S, 186787040S, 186788090S, 186788300S, 286782110, 186789480S, 186787050S, 186787070S, 186715650S, 186715450S, 186717740S, 186789035SModel VIPER Spine System Bone Screws, Viper Reusable Instruments for Insertion and Extraction, VIPER Spine System Rods, Cases and Trays for Spinal Medical Devices

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a002065S Basic UDI-DIDate18 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034456270 UDI-DIDate23 Dec 2020ListedStatusIn distribution

Coverage

2 jurisdictions

United 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 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 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 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 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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Viper 2 System EUDAMED
Viper 2 EUDAMED
Viper GUDID
Generic Name
Bone-screw internal spinal fixation system rod
Instrument tray, reusable
Orthopaedic inorganic implant inserter/extractor, reusable
Bone tap, reusable
Device Name
VIPER Spine System Straight Rods Straight Rod, Pre-Bent Rod, Pre-Kyphosed, Pre-Lordosed
Cases and Trays for Spinal Medical Devices
Model / Ref / Catalog
VIPER Spine System Bone Screws, 186715780S, 186715550S, 186715835S, 186715770S, 186715620S, 186717540S, 186715555S, 186715435S, 186717635S, 186715840S, 186715545S, 186717640S, 186715440S, 186715760S, Viper Reusable Instruments for Insertion and Extraction, 286735255, 186715660S, 186715730S, 186715535S, 286735252, 186715035S, 286705014, 186788090S, 286725405, 186788080S, 186788055S, VIPER Spine System Rods, 186789060S, Cases and Trays for Spinal Medical Devices, 186717650S, 186715845S, 186789090S, 186789140S, 186789150S, 186789080S, 186787150S, 186787040S, 186788300S, 286782110, 186789480S, 186787050S, 186787070S, 186715650S, 186715450S, 186717740S, 186789035S, 186788030S, 186788110S, 286715500
Primary DI / UDI-DI
10705034456270, 10705034410005, 10705034456874, 10705034456263, 10705034456652, 10705034456959, 10705034456645, 10705034456102, 10705034456843, 10705034456287, 10705034409993, 10705034456744, 10705034456119, 10705034456218, 10705034506562, 10705034456256, 10705034410074, 10705034409979, 10705034506555, 10705034456126, 10705034303376, 10705034238319, 10705034214382, 10705034238296, 10705034238241, 10705034238425, 10705034456751, 10705034456881, 10705034238487, 10705034238586, 10705034238609, 10705034238463, 10705034411743, 10705034238012, 10705034457246, 10705034215235, 10705034457260, 10705034238036, 10705034238074, 10705034410050, 10705034456638, 10705034456768, 10705034238371, 10705034238197, 10705034238357, 10705034214078
Basic UDI-DI
0705034a002065S, 0705034a001365W, 0705034a002105H, 0705034a0001159
Direct Marketing DI
10705034303376
10705034214382
FDA Product Code
KWQ, KWP, NKB, MNI, MNH, OSH, FSM, LXH, HWX
EMDN Code
P09070302, L091001, V0499
GMDN Term
Bone-screw internal spinal fixation system rod
Instrument tray, reusable
Orthopaedic inorganic implant inserter/extractor, reusable
Bone tap, reusable
Device Class
Class IIb EUDAMED
Class I EUDAMEDGUDID
Class II GUDID
Regulation Number
888.3060, 888.3050, 888.3070, 878.4800, 888.4540
Market of Registration
Belgium
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
Class I
GUDID
Class I
Class II

Manufacturer details

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

Related devices

Category: Spinal bone screw, non-bioabsorbable

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

  • Sterile YesEUDAMEDGUDIDNoEUDAMEDGUDID
  • Single Use YesGUDIDNoGUDID
  • Implantable YesEUDAMEDGUDIDNoEUDAMEDGUDID
  • Reusable NoEUDAMEDYesEUDAMED
  • Sutures
  • Prescription Use
  • Premarket Exempt NoGUDIDYesGUDID
  • Lot / Batch Number
  • Expiration Date YesGUDIDNoGUDID

Other properties (16)

  • 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
  • Serial Number: No
  • Manufacturing Date: No