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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
Ilion Medical Inc
825 Nicollet Mall Suite 715
Minneapolis,  MN  55402
Applicant Contact Tania Fuentes-Davitt
Ilion Medical Inc.
825 Nicollet Mall Suite 715
Minneapolis,  MN  55402
Correspondent Contact Tania Fuentes-Davitt
Regulation Number888.3040
Classification Product Code
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