• 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 pin, fixation, smooth
510(k) Number K122415
Device Name X-FIX DYNAMIC EXTERNAL DISTRACTOR
Applicant
AREX USA LLC
1709 hill st.
edgewater,  FL  32132
Applicant Contact charles hokanson
Correspondent
AREX USA LLC
1709 hill st.
edgewater,  FL  32132
Correspondent Contact charles hokanson
Regulation Number888.3040
Classification Product Code
HTY  
Date Received08/08/2012
Decision Date 03/15/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-