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: K170360
• 510k Number: K170360
• 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: 2017-02-06
• Decision Date: 2017-05-02
• Summary: summary