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 Neurological Stereotaxic Instrument
510(k) Number K113228
Device Name RENAISSANCE SYSTEM
Applicant
MAZOR ROBOTICS LTD
20 HATA'AS ST.
KFAR SABA,  IL 44425
Applicant Contact AHAVA STEIN
Correspondent
MAZOR ROBOTICS LTD
20 HATA'AS ST.
KFAR SABA,  IL 44425
Correspondent Contact AHAVA STEIN
Regulation Number882.4560
Classification Product Code
HAW  
Subsequent Product Code
LLZ  
Date Received11/01/2011
Decision Date 12/01/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-