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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 K191342
Device Name CrossRoads Screw System
Applicant
Crossroads Extemity Systems, LLC
6055 Primacy Pkwy., Suite 140
Memphis,  TN  38119
Applicant Contact Chad Hollis
Correspondent
Mrc-X, LLC
6075 Poplar Ave.
Memphis,  TN  38119
Correspondent Contact Theresa Leister
Regulation Number888.3040
Classification Product Code
HWC  
Date Received05/20/2019
Decision Date 08/19/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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