FDA 510(k) Application Details - K241034

Device Classification Name	More FDA Info for this Device
510(K) Number	K241034
Device Name	Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System
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	PML Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/16/2024
Decision Date	06/12/2024
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