FDA 510(k) Application Details - K221926

Device Classification Name	More FDA Info for this Device
510(K) Number	K221926
Device Name	Invictus« Bone Cement, Invictus Spinal Fixation System
Applicant	Alphatec Spine, Inc. 1950 Camino Vide Roble Carlsbad, CA 92008 US Other 510(k) Applications for this Company
Contact	Aditya Aiyer Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PML Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2022
Decision Date	12/20/2022
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