FDA 510(k) Application Details - K222789

Device Classification Name	More FDA Info for this Device
510(K) Number	K222789
Device Name	VADER« Pedicle System, G21 Cement
Applicant	icotec ag Industriestrasse 12 9450 Alstatten (SG) CH Other 510(k) Applications for this Company
Contact	Marina Hess 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	09/15/2022
Decision Date	01/09/2023
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