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 sacroiliac joint fixation
510(k) Number K190580
Device Name NADIA SI Fusion System
Applicant
Ilion Medical Inc
825 Nicollet Mall Suite 715
Minneapolis,  MN  55402
Applicant Contact Tania Fuentes-Davitt
Correspondent
Ilion Medical Inc.
825 Nicollet Mall Suite 715
Minneapolis,  MN  55402
Correspondent Contact Tania Fuentes-Davitt
Regulation Number888.3040
Classification Product Code
OUR  
Date Received03/06/2019
Decision Date 08/05/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-