FDA 510(k) Application Details - K211205

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K211205
Device Name	Appliance, Fixation, Spinal Intervertebral Body
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	888.3060   More FDA Info for this Regulation Number
Classification Product Code	KWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2021
Decision Date	08/12/2021
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