FDA 510(k) Application Details - K150064

Device Classification Name	Filler, Bone Void, Calcium Compound   More FDA Info for this Device
510(K) Number	K150064
Device Name	Filler, Bone Void, Calcium Compound
Applicant	ORTHOGEM LTD BIOCITY, PENNYFOOT STREET NOTTINGHAM NG1 1GF GB Other 510(k) Applications for this Company
Contact	PAUL Z MARKGRAF Other 510(k) Applications for this Contact
Regulation Number	888.3045   More FDA Info for this Regulation Number
Classification Product Code	MQV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/13/2015
Decision Date	09/04/2015
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