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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 K152072
Device Name CrossRoads Screw System
Applicant
Crossroads Extremity Systems, LLC
6055 Primacy Pkwy., Suite 140
Memphis,  TN  38119
Applicant Contact Vernon Hartgegen
Correspondent
Crossroads Extremity Systems, LLC
6055 Primacy Pkwy., Suite 140
Memphis,  TN  38119
Correspondent Contact Vernon Hartdegen
Regulation Number888.3040
Classification Product Code
HWC  
Date Received07/27/2015
Decision Date 09/23/2015
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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