FDA 510(k) Application Details - K231515

Device Classification Name	More FDA Info for this Device
510(K) Number	K231515
Device Name	MySpine Cervical Guides
Applicant	Medacta International S.A. Strada Regina Castel San Pietro 6874 CH Other 510(k) Applications for this Company
Contact	Stefano Baj Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/25/2023
Decision Date	12/07/2023
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