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Universal Navigation Expedium Spine System

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 275010050NModel Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems - Orthopaedic Surgery InstrumentsRef 286755005NModel Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems - Stereotactic Orthopaedic Surgery Instruments

by Medos International SARL

Identity

Trade Name
UNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM EUDAMED
UNIVERSAL NAVIGATION EUDAMED
NA FDA UDI
EXPEDIUM FDA UDI
Generic Name
Orthopaedic implant-instrument extension adaptor, reusable FDA UDI
Stereotactic surgery system probe, reusable FDA UDI
Device Name
Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems - Probes, awls, drivers EUDAMED
Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems - Handles, Adaptors, and Clamps EUDAMED
UNIVERSAL NAVIGATION BRAINLAB ADAPTOR FDA UDI
UNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM PEDICLE AWL FDA UDI
Model / Reference
Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems - Orthopaedic Surgery Instruments EUDAMED
275010050N EUDAMEDFDA UDI
286755005N EUDAMEDFDA UDI
Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems - Stereotactic Orthopaedic Surgery Instruments EUDAMED
Description
UNIVERSAL NAVIGATION BRAINLAB ADAPTOR FDA UDI
UNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM PEDICLE AWL FDA UDI

Identifiers

Catalog Number
286755005N FDA UDI
275010050N FDA UDI
Primary DI / UDI-DI
10705034388298 EUDAMEDFDA UDI
10705034515809 EUDAMEDFDA UDI
Basic UDI-DI
0705034a001505Q EUDAMED
0705034a001515S EUDAMED
Direct Marketing DI
10705034388298 EUDAMED
10705034515809 EUDAMED
510(k) Number
K140927 FDA UDI
K120867 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
Stereotactic surgery system probe, reusable FDA UDI

Classification

Device Class
Class IIa EUDAMED
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

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

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 Expedium Spine 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

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Manufacturer

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

Sources (4)

  • EUDAMED 7b36d9f8-91ac-45d4-9568-ccb0b2ffc962 61 fields · synced Jul 11, 2026
  • FDA UDI dbec1ac2-22d1-4071-a8b1-38fb9b541ba7 36 fields · synced May 30, 2026
  • FDA UDI 113e3d6e-deca-446d-9acf-e8818d8c5ecd 36 fields · synced May 30, 2026
  • EUDAMED 1042f6e2-fc7b-498b-91e2-b87dcf27429c 61 fields · synced Jul 8, 2026