FDA 510(k) Application Details - K190722

Device Classification Name	Staple, Fixation, Bone   More FDA Info for this Device
510(K) Number	K190722
Device Name	Staple, Fixation, Bone
Applicant	CrossRoads Extemity Systems, LLC 6055 Primacy Pkwy 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	JDR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/20/2019
Decision Date	08/16/2019
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