FDA 510(k) Application Details - K161225

Device Classification Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease   More FDA Info for this Device
510(K) Number	K161225
Device Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant	Paonan Biotech Co., Ltd. 3F, NO.50, LANE 258, RUEIGUANG RD., NEIHU DISTRICT, TAIPEI, R.O.C. TAIPEI 11491 TW Other 510(k) Applications for this Company
Contact	YI-JHEN TSAI Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	NKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/2016
Decision Date	08/11/2017
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