FDA 510(k) Application Details - K201210

Device Classification Name	Screw, Fixation, Intraosseous   More FDA Info for this Device
510(K) Number	K201210
Device Name	Screw, Fixation, Intraosseous
Applicant	Hager & Meisinger GmbH Hansemannstrasse 10 Neuss 41468 DE Other 510(k) Applications for this Company
Contact	Simon G÷ddeke Other 510(k) Applications for this Contact
Regulation Number	872.4880   More FDA Info for this Regulation Number
Classification Product Code	DZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/05/2020
Decision Date	10/08/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review