FDA 510(k) Application Details - K160605

Device Classification Name	More FDA Info for this Device
510(K) Number	K160605
Device Name	MectaLIF Anterior Stand-Alone
Applicant	MEDACTA INTERNATIONAL STRADA REGINA CASTEL SAN PIETRO CH 6874 CH Other 510(k) Applications for this Company
Contact	MICHAEL G. LOITERMAN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/02/2016
Decision Date	07/21/2016
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