FDA 510(k) Application Details - K181872

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K181872
Device Name	Plate, Fixation, Bone
Applicant	CrossRoads Extremity Systems, LLC 6055 Primacy Parkway, Suite 140 Memphis, TN 38119 US Other 510(k) Applications for this Company
Contact	Chad Hollis Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/12/2018
Decision Date	02/19/2019
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