VisAR

Orthopedic Stereotaxic Instrument

Novarad Corporation

The following data is part of a premarket notification filed by Novarad Corporation with the FDA for Visar.

Pre-market Notification Details

• Device ID: K220146
• 510k Number: K220146
• Device Name: VisAR
• Classification: Orthopedic Stereotaxic Instrument
• Applicant: Novarad Corporation 3152 North University Avenue, Suite 200 Provo, UT 84604
• Contact: Doug Merrill
• Correspondent: Doug Merrill; Novarad Corporation 3152 North University Avenue, Suite 200 Provo, UT 84604
• Product Code: OLO
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-01-19
• Decision Date: 2022-05-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B109VISAR2150	K220146	000
B109VISAR30670	K220146	000