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: K152574
• 510k Number: K152574
• 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: KRR
• Subsequent Product Code: NPJ
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-09-09
• Decision Date: 2015-10-20
• Summary: summary