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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 K241813
Device Name SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System
Applicant
Si-Technology, LLC
320 E. Vine Dr., Suite 217
Fort Collins,  CO  80524
Applicant Contact Donner Chris
Correspondent
Secure BioMed Evaluations
7828 Hickory Flat Highway Suite 120
Woodstock,  GA  30188
Correspondent Contact Justin Gracyalny
Regulation Number888.3040
Classification Product Code
OUR  
Date Received06/21/2024
Decision Date 08/13/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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