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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K241050
Device Name CrossRoads Modular Tray System
Applicant
Crossroads Extremity Systems
6423 Shelby View Dr.
Suite 101
Memphis,  TN  38134
Applicant Contact Jacqueline Gorberg
Correspondent
Crossroads Extremity Systems
6423 Shelby View Dr.
Suite 101
Memphis,  TN  38134
Correspondent Contact Jacqueline Gorberg
Regulation Number880.6850
Classification Product Code
KCT  
Date Received04/17/2024
Decision Date 07/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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