FDA 510(k) Application Details - K153439

Device Classification Name	Orthosis, Cervical Pedicle Screw Spinal Fixation   More FDA Info for this Device
510(K) Number	K153439
Device Name	Orthosis, Cervical Pedicle Screw Spinal Fixation
Applicant	L&K BIOMED CO., LTD. #201, 202 16-25, DONGBAEKJUNGANG-RO 16 BEON-GIL Giheung-gu, Yongin-si 446-916 KR Other 510(k) Applications for this Company
Contact	Yerim An Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	NKG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/27/2015
Decision Date	07/21/2016
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