FDA 510(k) Application Details - K200596

Device Classification Name	More FDA Info for this Device
510(K) Number	K200596
Device Name	G21 Cement, VADER« Pedicle System
Applicant	Icotec AG Industriestrasse 12 9450 Altstaetten 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	03/06/2020
Decision Date	10/13/2020
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