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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K230591
Device Name TriLEAP Plating System
Applicant
Crossroads Extremity Systems
6423 Shelby View Dr.
Suite 101
Memphis,  TN  38134
Applicant Contact Keith Knapp
Correspondent
Crossroads Extremity Systems
6423 Shelby View Dr.
Suite 101
Memphis,  TN  38134
Correspondent Contact Keith Knapp
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received03/03/2023
Decision Date 09/29/2023
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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