FDA 510(k) Application Details - K193061

Device Classification Name	Bone Cement   More FDA Info for this Device
510(K) Number	K193061
Device Name	Bone Cement
Applicant	G21 S.r.l Via S. Pertini, 8 San Possidonio 41039 IT Other 510(k) Applications for this Company
Contact	Flilippo Foroni 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	11/01/2019
Decision Date	03/19/2020
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