FDA 510(k) Application Details - K190762

Device Classification Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease   More FDA Info for this Device
510(K) Number	K190762
Device Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant	GBS Commonwealth Co., Ltd. C-309, Woolim Lion's Valley, 168, Gasan Digital 1-ro Geumcheon-gu 08507 KR Other 510(k) Applications for this Company
Contact	Jimmy Kim 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	03/25/2019
Decision Date	06/19/2019
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