NAVITRACK

Neurological Stereotaxic Instrument

ORTHOSOFT, INC.

The following data is part of a premarket notification filed by Orthosoft, Inc. with the FDA for Navitrack.

Pre-market Notification Details

• Device ID: K981315
• 510k Number: K981315
• Device Name: NAVITRACK
• Classification: Neurological Stereotaxic Instrument
• Applicant: ORTHOSOFT, INC. 40 BATES RD., SUITE 240 Outremont, Quebec, CA H2v 1a8
• Contact: Nicole Landreville
• Correspondent: Nicole Landreville; ORTHOSOFT, INC. 40 BATES RD., SUITE 240 Outremont, Quebec, CA H2v 1a8
• Product Code: HAW
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-04-10
• Decision Date: 1998-07-09
• Summary: summary