AxiEM™ Spine Reference Clamp

FDA UDI

Class II (US FDA UDI)

by Medtronic Navigation, Inc.

Identity

Trade Name: AxiEM™ Spine Reference Clamp FDA UDI
Generic Name: Multi-purpose stereotactic surgery system FDA UDI
Device Name: INST KIT 9735164 LIGHT REF CLAMP FDA UDI
Model / Reference: 9735164 FDA UDI
Description: INST KIT 9735164 LIGHT REF CLAMP FDA UDI

Identifiers

Primary DI / UDI-DI: 00643169309593 FDA UDI
FDA Product Code: HAW 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

AxiEM™ Spine Reference Clamp by Medtronic Navigation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Multi-purpose stereotactic surgery system.

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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

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Manufacturer

Manufacturer: Medtronic Navigation, Inc.

Sources (1)

FDA UDI bf3fe70c-ec70-4e64-a9c7-ea49a94ea151 34 fields · synced Jun 8, 2026