Navigation Enabled Instruments

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref 3010-19-003Model Navigation Enabled Instruments for the Thoracic-Lumbar-Sacral Spine510(k) K200791

by Medos International SARL

Identity

Trade Name: NAVIGATION ENABLED INSTRUMENTS EUDAMED
EXPEDIUM FDA UDI
Generic Name: Surgical screwdriver, reusable FDA UDI
Device Name: Navigation Enabled Driver Shaft Sleeve Awl Tip Tap for the Thoracic-Lumbar-Sacral Spine EUDAMED
NAVIGATION ENABLED INSTRUMENTS EXPEDIUM DRIVER - SHAFT T20 5.5 FDA UDI
Model / Reference: Navigation Enabled Instruments for the Thoracic-Lumbar-Sacral Spine EUDAMED
3010-19-003 EUDAMEDFDA UDI
Description: NAVIGATION ENABLED INSTRUMENTS EXPEDIUM DRIVER - SHAFT T20 5.5 FDA UDI

Identifiers

Catalog Number: 301019003 FDA UDI
Primary DI / UDI-DI: 10705034561387 EUDAMEDFDA UDI
Basic UDI-DI: 0705034a002355Z EUDAMED
Direct Marketing DI: 10705034561387 EUDAMED
FDA Product Code: OLO FDA UDI
EMDN Code: Z12130480 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
GMDN Term: Surgical screwdriver, reusable FDA UDI

Classification

Device Class: Class IIa 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

Navigation Enabled Instruments by Medos International Sarl — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — 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

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K200791	Class IIa	Active
EUDAMED	European Union	CE/MDR	0705034a002355Z	Class IIa	Active

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Manufacturer

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

Sources (3)

EUDAMED 69a59247-851a-4095-a725-806cd8e69a5c 85 fields · synced Jun 18, 2026
FDA UDI 06c6fed2-f204-413c-8ac2-36068ab777ed 35 fields · synced May 30, 2026
FDA 510(k) K200791 1 fields · synced May 18, 2026