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 Thoracolumbosacral Pedicle Screw System
510(k) Number K201457
Device Name Auxein Brand Vertaux 5.5 mm Pedicle Screw System
Applicant
Auxein Medical Private Limited/71164
Plot #168,169,170, Phase-Iv, Sector 57, Kundli Industrial
Area
Sonipat,  IN 131028
Applicant Contact Gaurav Luthra
Correspondent
Auxein Medical Private Limited/71164
Plot #168,169,170 Phase-Iv,
Kundli Industrial Area, Hsiidc, Sector-57
Sonepat,  IN 131028
Correspondent Contact Rahul Luthra
Regulation Number888.3070
Classification Product Code
NKB  
Date Received06/01/2020
Decision Date 04/06/2021
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
-
-