FDA 510(k) Application Details - K240126

Device Classification Name	More FDA Info for this Device
510(K) Number	K240126
Device Name	ProAM ALIF System
Applicant	Pro Surgical, Inc. 3875 Copper Crest Rd. Encinitas, CA 92024 US Other 510(k) Applications for this Company
Contact	Blain Jason Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/2024
Decision Date	05/03/2024
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