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 dental stereotaxic instrument
510(k) Number K192579
Device Name X-Guide Surgical Navigation System
Applicant
X-Nav Technologies, LLC
1555 Bustard Road, Suite 75
Lansdale,  PA  19446
Applicant Contact Fred Cowdery
Correspondent
X-Nav Technologies, LLC
1555 Bustard Road, Suite 75
Lansdale,  PA  19446
Correspondent Contact Fred Cowdery
Regulation Number872.4120
Classification Product Code
PLV  
Date Received09/19/2019
Decision Date 02/03/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-