• 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 sacroiliac joint fixation
510(k) Number K221047
Device Name SILO TFX MIS Sacroiliac Joint Fixation System
Aurora Spine, Inc.
1930 Palomar Point Way, Suite #103
Carlsbad,  CA  92008
Applicant Contact Laszlo Garamszegi
803 7th Street NW
Washington,  DC  20001
Correspondent Contact Samuel Pollard
Regulation Number888.3040
Classification Product Code
Date Received04/08/2022
Decision Date 10/03/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No