FDA 510(k) Application Details - K200793

Device Classification Name	Orthosis, Cervical Pedicle Screw Spinal Fixation   More FDA Info for this Device
510(K) Number	K200793
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 17015 KR Other 510(k) Applications for this Company
Contact	KiHyang Kim 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	03/26/2020
Decision Date	10/08/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review