FDA 510(k) Application Details - K151362

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K151362
Device Name	Orthosis, Spondyloisthesis Spinal Fixation
Applicant	HUNG CHUN BIO-S CO., LTD. NO.12, LUKE 1ST RD., LUZHU DIST., KAOHSIUNG CITY 821 TW Other 510(k) Applications for this Company
Contact	HSIN TAI HU Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	MNH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/21/2015
Decision Date	05/05/2016
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