FDA 510(k) Application Details - K211496

Device Classification Name	More FDA Info for this Device
510(K) Number	K211496
Device Name	TransLoc 3D
Applicant	Foundation Fusion Solutions, LLC (dba CornerLoc) 11916 S. Oxford Ave., Suite 206 Tulsa, OK 74137 US Other 510(k) Applications for this Company
Contact	Robert Compton Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/13/2021
Decision Date	07/27/2022
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