FDA 510(k) Application Details - K212139

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K212139
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 US Other 510(k) Applications for this Company
Contact	Cindy Fong 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	07/08/2021
Decision Date	09/01/2021
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