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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 K214123
Device Name T-FIX® 3DSI Joint Fusion System
Applicant
Cutting Edge Spine, LLC
6012 Waxhaw Hwy
Mineral Springs,  NC  28108
Applicant Contact Kyle Kuntz
Correspondent
Cutting Edge Spine, LLC
6012 Waxhaw Hwy
Mineral Springs,  NC  28108
Correspondent Contact Kyle Kuntz
Regulation Number888.3040
Classification Product Code
OUR  
Date Received12/30/2021
Decision Date 06/24/2022
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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