FDA.reportPublic FDA data

MAZOR ROBOTICS LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30050756963005075696MAZOR ROBOTICS LTD.1N2026-01-011 HaEshel Street (Building C), Caesarea Business Park Caesarea Haifa IL 3079830

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2284881630090136K251316Mazor X System / Mazor X Stealth EditionOLO2025-09-11
2284881301174916K230064Mazor X System (Mazor X Stealth Edition)OLO2023-04-07
2284881946850983K203005Mazor XOLO2020-10-27
2284881684133211K200935Mazor XOLO2020-05-08
2284881697327429K182077Mazor X System (Mazor X Stealth Edition)OLO2018-11-02
2284881360501243K180307Mazor XOLO2018-04-30
2284881355391832K172522Mazor XOLO2017-09-15
2284881755986969K163221Mazor XOLO2017-04-04
2284881326668826K152041Renaissance X SystemOLO2015-11-17
2284881221532598K140167RENAISSANCE X SYSTEMOLO2014-09-10
2284881680980577K120812RENAISSANCEHAW2012-07-12
2284881276669756K113228RENAISSANCE SYSTEMHAW2011-12-01
2284882047297257K110911RENAISSANCE SYSTEMHAW2011-04-28

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OLO102025-09-11
HAW32012-07-12

PMN#

Mazor X

2020-10-27

Mazor Robotics , Ltd.

Mazor X

2020-05-08

Mazor Robotics Ltd.

Mazor X

2018-04-30

Mazor Robotics Ltd.

Mazor X

2017-09-15

Mazor Robotics Ltd.

Mazor X

2017-04-04

Mazor Robotics Ltd.

GUDID#

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