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 K233903
Device Name Zeta Cranial Navigation System (ZNS131-US)
Applicant
Zeta Surgical Inc
115 Kingston St
Floor 2
Boston,  MA  02111
Applicant Contact Roman Stolyarov
Correspondent
Zeta Surgical Inc
115 Kingston St
Floor 2
Boston,  MA  02111
Correspondent Contact Roman Stolyarov
Regulation Number882.4560
Classification Product Code
HAW  
Date Received12/11/2023
Decision Date 01/10/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-