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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 K223819
Device Name SI-Cure Sacroiliac Joint Fusion System
Alevio, LLC
200 Cahaba Park, Suite 100
Birmingham,  AL  35242
Applicant Contact Trey Robbins
Empirical Technologies
4628 Northpark Drive
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number888.3040
Classification Product Code
Date Received12/21/2022
Decision Date 01/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No