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FDA 510(k), K163221, Mazor X
FDA 510(k), K163221, Mazor X
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510(K) Number: K163221
Device Name: Mazor X
Manufacturer: Mazor Robotics Ltd.
Device Classification Name: Orthopedic Stereotaxic Instrument
Regulation Number: 882.4560
Classification Product Code: OLO
Date Received: 11/16/2016
Decision Date: 04/04/2017
Regulation Medical Specialty: Neurology
Device Name: Mazor X
Manufacturer: Mazor Robotics Ltd.
Device Classification Name: Orthopedic Stereotaxic Instrument
Regulation Number: 882.4560
Classification Product Code: OLO
Date Received: 11/16/2016
Decision Date: 04/04/2017
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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