← Back to catalogue

Universal Navigation Viper System

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 286715600NModel Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems - Orthopaedic Surgery InstrumentsRef 179706070SModel VIPER Spine System Bone ScrewsRef 186720740S

by Medos International SARL

Identity

Trade Name
UNIVERSAL NAVIGATION VIPER SYSTEM EUDAMED
VIPER SYSTEM EUDAMED
VIPER FDA UDI
Generic Name
Stereotactic surgery system probe, reusable FDA UDI
Device Name
Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems - Probes, awls, drivers EUDAMED
Viper Spine System Bone Screws Cannulated Polyaxial Screw, Cannulated Monoaxial Screw, Cannulated Uniplanar Screw, Cannulated Extended Tab Polyaxial Screw, Polyaxial Wide Lag Screw, Polyaxial Fully Threaded Screw, X-TAB Polyaxial Screw, CFX X-TAB Polyaxi EUDAMED
UNIVERSAL NAVIGATION VIPER SYSTEM TAP, DUAL LEAD CANNULATED 6mm FDA UDI
Model / Reference
Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems - Orthopaedic Surgery Instruments EUDAMED
286715600N EUDAMEDFDA UDI
VIPER Spine System Bone Screws EUDAMED
179706070S EUDAMED
186720740S EUDAMED
Description
UNIVERSAL NAVIGATION VIPER SYSTEM TAP, DUAL LEAD CANNULATED 6mm FDA UDI

Identifiers

Catalog Number
286715600N FDA UDI
Primary DI / UDI-DI
10705034388496 EUDAMEDFDA UDI
10705034605388 EUDAMED
10705034605043 EUDAMED
Basic UDI-DI
0705034a001505Q EUDAMED
0705034a002065S EUDAMED
Direct Marketing DI
10705034388496 EUDAMED
510(k) Number
K120867 FDA UDI
K140927 FDA UDI
FDA Product Code
OLO FDA UDI
EMDN Code
Z12130480 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
GMDN Term
Stereotactic surgery system probe, reusable FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
882.4560 FDA UDI
Market of Registration
Belgium EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDIEUDAMED

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDIEUDAMED

Reusable

Yes

EUDAMEDEUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

Yes

EUDAMEDEUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Multi-purpose stereotactic surgery system

Universal Navigation Viper System by Medos International Sarl — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-purpose stereotactic surgery system.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medos International SARL
EUDAMED SRN
CH-MF-000014268
Authorised Representative
DePuy Ireland UC IE-AR-000009328

Sources (4)

  • EUDAMED 8aab7b6b-a83a-4dc5-99ba-8af239858b22 61 fields · synced Jul 26, 2026
  • EUDAMED 35dae99c-4db4-4420-a3f7-037414706cc4 61 fields · synced May 17, 2026
  • EUDAMED 187d7e1e-c195-4242-8d60-68f65e731af9 61 fields · synced May 17, 2026
  • FDA UDI 3b2cd99a-afab-418f-b243-5d982fa24759 36 fields · synced May 30, 2026