FDA 510(k) Application Details - K200615

Device Classification Name	More FDA Info for this Device
510(K) Number	K200615
Device Name	Signature ONE System
Applicant	Orthosoft Inc. (d/b/a Zimmer CAS) 75 Queen Street Suite 3300 Montreal H3C 2N6 CA Other 510(k) Applications for this Company
Contact	Sankalp Dere Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QHE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/09/2020
Decision Date	06/05/2020
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