510(k) K180307

Mazor X by Mazor Robotics , Ltd. — Product Code OLO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 30, 2018
Date Received: February 2, 2018
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Orthopedic Stereotaxic Instrument
Device Class: Class II
Regulation Number: 882.4560
Review Panel: OR
Submission Type

Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

Other clearances by Mazor Robotics , Ltd.

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K200935 — Mazor X (May 8, 2020)
K182077 — Mazor X System (Mazor X Stealth Edition) (November 2, 2018)
K172522 — Mazor X (September 15, 2017)
K163221 — Mazor X (April 4, 2017)
K152041 — Renaissance X System (November 17, 2015)
K140167 — RENAISSANCE X SYSTEM (September 10, 2014)
K120812 — RENAISSANCE (July 12, 2012)

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