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 K230661
Device Name Zeta Cranial Navigation System
Applicant
Zeta Surgical
2 Park Plaza, Suite 400
Boston,  MA  02116
Applicant Contact Jose Amich
Correspondent
Zeta Surgical
2 Park Plaza, Suite 400
Boston,  MA  02116
Correspondent Contact Roman Stolyarov
Regulation Number882.4560
Classification Product Code
HAW  
Date Received03/10/2023
Decision Date 09/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-