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: K140596
• 510k Number: K140596
• Device Name: NAVIO
• Classification: Orthopedic Stereotaxic Instrument
• Applicant: BLUE BELT TECHNOLOGIES, INC. 2828 LIBERTY AVENUE SUITE 100 Pittsburgh, PA 15222
• Contact: Richard G Confer
• Correspondent: Richard G Confer; BLUE BELT TECHNOLOGIES, INC. 2828 LIBERTY AVENUE SUITE 100 Pittsburgh, PA 15222
• Product Code: OLO
• Subsequent Product Code: HRY
• Subsequent Product Code: HSX
• Subsequent Product Code: KRR
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-03-07
• Decision Date: 2014-07-02
• Summary: summary