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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
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