FDA 510(k) Application Details - K242517

Device Classification Name	More FDA Info for this Device
510(K) Number	K242517
Device Name	ProAM ACDF System
Applicant	Pro Surgical, Inc. 1910 Palomar Point Way, Suite 201 Carlsbad, CA 92008 US Other 510(k) Applications for this Company
Contact	Jason Blain 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	08/23/2024
Decision Date	11/20/2024
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