FDA 510(k) Application Details - K151270

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K151270
Device Name	Screw, Fixation, Bone
Applicant	CrossRoads Extremity Systems LLC 6055 Primacy Parkway, Suite 140 Memphis, TN 38119 US Other 510(k) Applications for this Company
Contact	Vernon Hartdegen Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/13/2015
Decision Date	09/04/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review