Medtronic

FDA UDI

Class II (US FDA UDI)

by Medtronic Navigation, Inc.

Identity

Trade Name: Medtronic FDA UDI
Generic Name: Multi-purpose stereotactic surgery system FDA UDI
Device Name: REF SET 9736428 SPINE REFERENCING FDA UDI
Model / Reference: 9736428 FDA UDI
Description: REF SET 9736428 SPINE REFERENCING FDA UDI

Identifiers

Primary DI / UDI-DI: 00763000971441 FDA UDI
510(k) Number: K211442 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

Yes

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

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

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Cleared under the same submission

K211442 also covers:

Medtronic — MEDTRONIC NAVIGATION, INC.

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

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Manufacturer

Manufacturer: Medtronic Navigation, Inc.

Sources (1)

FDA UDI 19c79dbe-2bf5-4fe4-ae19-5c11cec4c2fd 35 fields · synced Jun 8, 2026