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 Component, Traction, Invasive
510(k) Number K193256
Device Name Anjon Bremer Halo System
Applicant
Anjon Holdings, LLC
4801 Dawin Rd.
Jacksonville,  FL  32207
Applicant Contact Kenneth A Collins
Correspondent
Anjon Holdings, LLC
4801 Dawin Rd.
Jacksonville,  FL  32207
Correspondent Contact Kenneth A Collins
Regulation Number888.3040
Classification Product Code
JEC  
Date Received11/26/2019
Decision Date 03/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-