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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K252699
Device Name CoAptix S System
Applicant
University of Utah, Department of Orthopaedics
590 Wakara Way
Salt Lake City,  UT  84108
Applicant Contact Wade Fallin
Correspondent
Mcra, LLC
803 7th Street NW, 3rd Floor
Washington,  DC  20001
Correspondent Contact Dave McGurl
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received08/27/2025
Decision Date 04/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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