NAVIO™ Surgical System (NAVIO System)

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™ Surgical System (navio System).

Pre-market Notification Details

• Device ID: K180271
• 510k Number: K180271
• Device Name: NAVIO™ Surgical System (NAVIO System)
• Classification: Orthopedic Stereotaxic Instrument
• Applicant: Blue Belt Technologies, Inc. 2905 Northwest Blvd. Ste. 40 Plymouth, MN 55441
• Contact: Corrine Herlinger
• Correspondent: Corrine Herlinger; 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: 2018-01-31
• Decision Date: 2018-04-06
• Summary: summary