FDA 510(k) Application Details - K203129

Device Classification Name	More FDA Info for this Device
510(K) Number	K203129
Device Name	NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System
Applicant	Precision Spine, Inc. 2050 Executive Drive Pearl, MS 39208 US Other 510(k) Applications for this Company
Contact	Michael Dawson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/19/2020
Decision Date	01/12/2021
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