FDA 510(k) Application Details - K180758

Device Classification Name	Filler, Bone Void, Calcium Compound   More FDA Info for this Device
510(K) Number	K180758
Device Name	Filler, Bone Void, Calcium Compound
Applicant	Wiltrom Corporation Limited 1F., No. 26, Sec. 2, Shengyi Rd. Zhubei City 30261 TW Other 510(k) Applications for this Company
Contact	Yi-Chun Su 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	03/22/2018
Decision Date	10/24/2018
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