RENAISSANCE

Neurological Stereotaxic Instrument

MAZOR ROBOTICS LTD

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

Pre-market Notification Details

• Device ID: K120812
• 510k Number: K120812
• Device Name: RENAISSANCE
• Classification: Neurological Stereotaxic Instrument
• Applicant: MAZOR ROBOTICS LTD 20 HATA'AS ST. BOX 124 SUITE 213 BEIT HAPA'AMON Kfar Saba, IL 44425
• Contact: Ahava Stein
• Correspondent: Ahava Stein; MAZOR ROBOTICS LTD 20 HATA'AS ST. BOX 124 SUITE 213 BEIT HAPA'AMON Kfar Saba, IL 44425
• Product Code: HAW
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-03-16
• Decision Date: 2012-07-12
• Summary: summary