FDA 510(k) Application Details - K190565

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K190565
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	EiserTech, LLC 9988 Hibert Street Suite 302 San Diego, CA 92131 US Other 510(k) Applications for this Company
Contact	Lukas Eisermann 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	03/05/2019
Decision Date	05/31/2019
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