FDA 510(k) Application Details - K210286

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K210286
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	Meditech Spine, LLC 1447 Peachtree St NE Suite 440 Atlanta, GA 30309 US Other 510(k) Applications for this Company
Contact	Bruce Dunaway 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	02/02/2021
Decision Date	03/18/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review