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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 K231951
Device Name SI-Cure Sacroiliac Joint Fusion System
Applicant
Alevio, LLC
200 Cahaba Park Cir.
Suite 100
Birmingham,  AL  35242
Applicant Contact Trey Robbins
Correspondent
Empirical Technologies
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number888.3040
Classification Product Code
OUR  
Subsequent Product Code
HWC  
Date Received06/30/2023
Decision Date 07/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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