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Viper 186789150

by Depuy Spine, Inc.

Ref 186789150Model VIPER Spine System Rods

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a002105H Basic UDI-DIDate18 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034132860 UDI-DIDate24 Sep 2015ListedStatusListed GUDID: in commercial distribution

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

1 recall · FDA

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

    Device does not mate as intended.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
VIPER2 System EUDAMED
Viper GUDID
Generic Name
Bone-screw internal spinal fixation system rod
Device Name
VIPER Spine System Straight Rods Straight Rod, Pre-Bent Rod, Pre-Kyphosed, Pre-Lordosed
Model / Ref / Catalog
186789150, VIPER Spine System Rods
Primary DI / UDI-DI
10705034132860
Basic UDI-DI
0705034a002105H
510(k) Number
FDA Product Code
KWP, MNH, KWQ, NKB, OSH, MNI
EMDN Code
P09070302 Thoracolumbosacral fixation systems
GMDN Term
Bone-screw internal spinal fixation system rod
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3050, 888.3070, 888.3060
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

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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