FDA 510(k) Application Details - K123225

Device Classification Name	Bone Cement   More FDA Info for this Device
510(K) Number	K123225
Device Name	Bone Cement
Applicant	AAP BIOMATERIALS GMBH & CO. KG LAGERSTRASSE 11-15 DIEBURG 64807 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	10/15/2012
Decision Date	03/15/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review