FDA 510(k) Application Details - K153737

Device Classification Name	Bone Cement   More FDA Info for this Device
510(K) Number	K153737
Device Name	Bone Cement
Applicant	HERAEUS MEDICAL GMBH PHILIPP-REIS-STR. 8-13 WEHRHEIM 61273 DE Other 510(k) Applications for this Company
Contact	ASTRID MARX 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	12/28/2015
Decision Date	04/22/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review