Mazor X

Orthopedic Stereotaxic Instrument

Mazor Robotics Ltd.

The following data is part of a premarket notification filed by Mazor Robotics Ltd. with the FDA for Mazor X.

Pre-market Notification Details

• Device ID: K163221
• 510k Number: K163221
• Device Name: Mazor X
• Classification: Orthopedic Stereotaxic Instrument
• Applicant: Mazor Robotics Ltd. 7 HaEshel St. Caesarea, IL 3088900
• Contact: Ayelet Matia
• Correspondent: Ahava Stein; A. Stein - Regulatory Affairs Consulting Ltd. 20 Hatas St. Kfar Saba, IL
• Product Code: OLO
• Subsequent Product Code: HAW
• Subsequent Product Code: LLZ
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-11-16
• Decision Date: 2017-04-04
• Summary: summary