FDA 510(k) Application Details - K220797

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K220797
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	CrossRoads Extremity Systems, LLC 6423 Shelby View Dr., Suite 101 Memphis, TN 38134 US Other 510(k) Applications for this Company
Contact	Kim Strohkirch Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	MBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/18/2022
Decision Date	04/15/2022
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