FDA 510(k) Application Details - K200523

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K200523
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	Elite Surgical Supplies (PTY) LTD 54 De Havilland Cresent, Persequor Technopark Pretoria 0020 ZA Other 510(k) Applications for this Company
Contact	Thanos Spirakis 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	03/02/2020
Decision Date	04/30/2020
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