NAVIO

Orthopedic Stereotaxic Instrument

Blue Belt Technologies, Inc.

The following data is part of a premarket notification filed by Blue Belt Technologies, Inc. with the FDA for Navio.

Pre-market Notification Details

• Device ID: K191223
• 510k Number: K191223
• Device Name: NAVIO
• Classification: Orthopedic Stereotaxic Instrument
• Applicant: Blue Belt Technologies, Inc. 2905 Northwest Blvd., Ste. 40 Plymouth, MN 55441
• Contact: Amy Winegarden
• Correspondent: Amy Winegarden; Blue Belt Technologies, Inc. 2905 Northwest Blvd., Ste. 40 Plymouth, MN 55441
• Product Code: OLO
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-05-07
• Decision Date: 2019-06-28

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885556709405	K191223	000
00885556709399	K191223	000
00885556709382	K191223	000