FDA 510(k) Application Details - K232425

Device Classification Name	More FDA Info for this Device
510(K) Number	K232425
Device Name	SignatureÖ 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	Nilam Dave 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	08/11/2023
Decision Date	12/12/2023
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