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O-Arm®

FDA UDI

Class II (US FDA UDI)

by Medtronic Navigation, Inc.

Identity

Trade Name
O-ARM® FDA UDI
Generic Name
Portable general-purpose fluoroscopic x-ray system, digital FDA UDI
Device Name
MOUSE 9732721 STERILE O-ARM 10PK FDA UDI
Model / Reference
9732721 FDA UDI
Description
MOUSE 9732721 STERILE O-ARM 10PK FDA UDI

Identifiers

Primary DI / UDI-DI
20885074546180 FDA UDI
510(k) Number
K060344 FDA UDI
FDA Product Code
OXO FDA UDI
GMDN Term
Portable general-purpose fluoroscopic x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1650 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Category: Portable general-purpose fluoroscopic x-ray system, digital

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

Similar devices

Also classified as Portable general-purpose fluoroscopic x-ray system, digital.

Cleared under the same submission

K060344 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Navigation, Inc.

Sources (1)

  • FDA UDI d3788508-1df0-42cf-8ddc-f342b69d9c5b 35 fields · synced Jun 8, 2026