FDA 510(k) Application Details - K232878

Device Classification Name	More FDA Info for this Device
510(K) Number	K232878
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	09/18/2023
Decision Date	10/17/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review