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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K220797
Device Name FootHold System
Applicant
Crossroads Extremity Systems, LLC
6423 Shelby View Dr.
Suite 101
Memphis,  TN  38134
Applicant Contact Kim Strohkirch
Correspondent
Crossroads Extremity Systems, LLC
6423 Shelby View Dr.
Suite 101
Memphis,  TN  38134
Correspondent Contact Kim Strohkirch
Regulation Number888.3040
Classification Product Code
MBI  
Date Received03/18/2022
Decision Date 04/15/2022
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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