FDA 510(k) Application Details - K210120

Device Classification Name	Bone Cement   More FDA Info for this Device
510(K) Number	K210120
Device Name	Bone Cement
Applicant	Osartis GmbH Auf der Beune 101 Munster 64839 DE Other 510(k) Applications for this Company
Contact	Volker Stirnal Other 510(k) Applications for this Contact
Regulation Number	888.3027   More FDA Info for this Regulation Number
Classification Product Code	LOD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/19/2021
Decision Date	03/19/2021
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