FDA 510(k) Application Details - K191584

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K191584
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	Camber Spine Technologies LLC 501 Allendale Road King of Prussia, PA 19406 US Other 510(k) Applications for this Company
Contact	Rami Hamzey 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	06/14/2019
Decision Date	10/22/2019
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