Universal Navigation

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 286755011NModel Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems - Stereotactic Orthopaedic Surgery Instruments

by Medos International SARL

Identity

Trade Name: UNIVERSAL NAVIGATION EUDAMED
NA FDA UDI
Generic Name: Orthopaedic implant-instrument extension adaptor, reusable FDA UDI
Device Name: Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems - Handles, Adaptors, and Clamps EUDAMED
UNIVERSAL NAVIGATION CLAMP ATTACHMENT, LARGE FDA UDI
Model / Reference: Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems - Stereotactic Orthopaedic Surgery Instruments EUDAMED
286755011N EUDAMEDFDA UDI
Description: UNIVERSAL NAVIGATION CLAMP ATTACHMENT, LARGE FDA UDI

Identifiers

Catalog Number: 286755011N FDA UDI
Primary DI / UDI-DI: 10705034472232 EUDAMEDFDA UDI
Basic UDI-DI: 0705034a001515S EUDAMED
Direct Marketing DI: 10705034472232 EUDAMED
510(k) Number: K140927 FDA UDI
FDA Product Code: OLO FDA UDI
EMDN Code: Z12130480 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
GMDN Term: Orthopaedic implant-instrument extension adaptor, reusable FDA UDI

Classification

Device Class: Class I 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

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Multi-purpose stereotactic surgery system

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

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Also classified as Multi-purpose stereotactic surgery system.

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	0705034a001515S	Class I	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

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

Sources (2)

EUDAMED e124e68b-8d18-4471-99f1-b53c185246d7 61 fields · synced May 30, 2026
FDA UDI e99eab82-b1b3-412e-be0a-a275d4715113 36 fields · synced May 30, 2026