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: K172522
• 510k Number: K172522
• Device Name: Mazor X
• Classification: Orthopedic Stereotaxic Instrument
• Applicant: Mazor Robotics Ltd. 5 Shacham St. North Industrial Park Caesarea, IL 3088900
• Contact: Shiran Conforti
• Correspondent: Ahava Stein; A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as St. Beit Hapaamon, Suite 102 Kfar Saba, IL 4442520
• Product Code: OLO
• Subsequent Product Code: HAW
• Subsequent Product Code: LLZ
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-08-21
• Decision Date: 2017-09-15
• Summary: summary