Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K251316
Device Name Mazor X System / Mazor X Stealth Edition
Applicant
Mazor Robotics , Ltd.
1 Haeshel St. (Bldg. C), Caesarea Buisness Park
Caeasarea,  IL 3079830
Applicant Contact Anat Marom
Correspondent
Mazor Robotics , Ltd.
1 Haeshel St. (Bldg. C), Caesarea Buisness Park
Caeasarea,  IL 3079830
Correspondent Contact Anat Marom
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Code
LLZ  
Date Received04/29/2025
Decision Date 09/11/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-