FDA 510(k) Application Details - K110949

Device Classification Name	Filler, Bone Void, Calcium Compound   More FDA Info for this Device
510(K) Number	K110949
Device Name	Filler, Bone Void, Calcium Compound
Applicant	WILTROM CORPORATION LIMITED NO. 221, SEC 1, CHUNG HSING RD CHUTUNG TOWNSHIP, HSINCHU 31053 TW Other 510(k) Applications for this Company
Contact	YUNG-CHIH WU 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	04/04/2011
Decision Date	09/18/2012
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