FDA 510(k) Application Details - K210035

Device Classification Name	More FDA Info for this Device
510(K) Number	K210035
Device Name	ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System
Applicant	Aegis Spine 9781 S. Meridian Blvd, Ste 300 Englewood, CO 80112 US Other 510(k) Applications for this Company
Contact	Kay Kwon Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/06/2021
Decision Date	02/16/2021
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