StealthStation Cranial Software V1.3.2

Neurological Stereotaxic Instrument

Medtronic Navigation, Inc.

The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Stealthstation Cranial Software V1.3.2.

Pre-market Notification Details

• Device ID: K203639
• 510k Number: K203639
• Device Name: StealthStation Cranial Software V1.3.2
• Classification: Neurological Stereotaxic Instrument
• Applicant: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, CO 80027
• Contact: Taylor Gold West
• Correspondent: Taylor Gold West; Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, CO 80027
• Product Code: HAW
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-12-14
• Decision Date: 2021-01-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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