Mazor Robotics , Ltd. is one of 267 FDA 510(k) medical device manufacturers from Israel in the dataset, ranked by real submission volume.
Mazor Robotics , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Mazor X System / Mazor X Stealth Edition, Mazor X System (Mazor X Stealth Edition), Mazor X
13
Total
13
Cleared
0
Denied
Mazor Robotics , Ltd. has 13 FDA 510(k) cleared orthopedic devices. Based in Kfar Saba, IL.
Latest FDA clearance: Sep 2025. Active since 2011.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by A. Stein - Regulatory Affairs Consulting , Ltd. and A. Stein – Regulatory Affairs Consulting , Ltd..
FDA 510(k) Regulatory Record - Mazor Robotics , Ltd.
13 devices
Cleared
Sep 11, 2025
Mazor X System / Mazor X Stealth Edition
Orthopedic
135d
Cleared
Apr 07, 2023
Mazor X System (Mazor X Stealth Edition)
Orthopedic
88d
Cleared
Oct 27, 2020
Mazor X
Orthopedic
26d
Cleared
May 08, 2020
Mazor X
Orthopedic
30d
Cleared
Nov 02, 2018
Mazor X System (Mazor X Stealth Edition)
Orthopedic
93d
Cleared
Apr 30, 2018
Mazor X
Orthopedic
87d
Cleared
Sep 15, 2017
Mazor X
Orthopedic
25d
Cleared
Apr 04, 2017
Mazor X
Orthopedic
139d
Cleared
Nov 17, 2015
Renaissance X System
Orthopedic
118d
Cleared
Sep 10, 2014
RENAISSANCE X SYSTEM
Orthopedic
230d
Cleared
Jul 12, 2012
RENAISSANCE
Radiology
118d
Cleared
Dec 01, 2011
RENAISSANCE SYSTEM
Radiology
30d