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: K160537
• 510k Number: K160537
• Device Name: Navio
• Classification: Orthopedic Stereotaxic Instrument
• Applicant: Blue Belt Technologies, Inc. 2905 Northwest Blvd. Ste 40 Plymouth, MN 55441
• Contact: Richard G. Confer
• Correspondent: Richard G. Confer; Blue Belt Technologies, Inc. 2905 Northwest Blvd. Ste 40 Plymouth, MN 55441
• Product Code: OLO
• Subsequent Product Code: HRY
• Subsequent Product Code: HSX
• Subsequent Product Code: JWH
• Subsequent Product Code: KRR
• Subsequent Product Code: NPJ
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-02-26
• Decision Date: 2016-05-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20885556648425	K160537	000
00885556684948	K160537	000