Stealth Autoguide System, Midas Rex Legend Depth Stop System

Neurological Stereotaxic Instrument

Medtronic Navigation, Inc.

The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Stealth Autoguide System, Midas Rex Legend Depth Stop System.

Pre-market Notification Details

• Device ID: K191597
• 510k Number: K191597
• Device Name: Stealth Autoguide System, Midas Rex Legend Depth Stop System
• Classification: Neurological Stereotaxic Instrument
• Applicant: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, CO 80027
• Contact: Jason Woehrle
• Correspondent: Jason Woehrle; Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, CO 80027
• Product Code: HAW
• Subsequent Product Code: HBB
• Subsequent Product Code: HBC
• Subsequent Product Code: HBE
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-06-17
• Decision Date: 2019-11-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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