• 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 orthopedic stereotaxic instrument
510(k) Number K190929
Device Name xvision Spine system (XVS)
Augmedics Ltd.
1 Ha-Tsmikha St
Yokneam lllit,  IL 2069205
Applicant Contact Tami Harel
Hogan Lovells US LLP
1735 Market Street, Floor 23
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number882.4560
Classification Product Code
Date Received04/09/2019
Decision Date 12/20/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No