SureTrak

FDA UDI

Class II (US FDA UDI)

by Medtronic Navigation, Inc.

Identity

Trade Name: SureTrak FDA UDI
Generic Name: Multi-purpose stereotactic surgery system FDA UDI
Device Name: INST KIT 9735161 SURETRAK II TRCKR TRAY FDA UDI
Model / Reference: 9735161 FDA UDI
Description: INST KIT 9735161 SURETRAK II TRCKR TRAY FDA UDI

Identifiers

Primary DI / UDI-DI: 00643169279858 FDA UDI
FDA Product Code: OLO FDA UDI
GMDN Term: Multi-purpose stereotactic surgery system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

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

SureTrak by Medtronic Navigation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-purpose stereotactic surgery system.

PEEK INSTRUMENT ADAPTOR Ø2.15MM — MEDTECH LLC · Class II
TRIALTIS Spine System — MEDOS INTERNATIONAL SARL · Class IIa
PEEK INSTRUMENT ADAPTOR Ø4.6MM — MEDTECH LLC · Class II
NIM-Spine — MEDTRONIC SOFAMOR DANEK, INC. · Class II
UNIVERSAL NAVIGATION VIPER SYSTEM — MEDOS INTERNATIONAL SARL · Class IIa
NAVIGATION ENABLED INSTRUMENTS — MEDOS INTERNATIONAL SARL · Class IIa
ROSA® KNEE PERSONA® ID PLATE — Zimmer CAS · Class I
Standard xvision tray, instruments included — AUGMEDICS LTD. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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

Manufacturer

Manufacturer: Medtronic Navigation, Inc.

Sources (1)

FDA UDI 5b35941a-e51f-4d67-ad83-daf2b95c5acc 34 fields · synced May 30, 2026