FDA 510(k) Application Details - K211614

Device Classification Name	More FDA Info for this Device
510(K) Number	K211614
Device Name	CenterMed Patient Matched Assisted Surgical Planning (ASP) System
Applicant	CenterMed, Inc. 226 N Wiget Ln Walnut Creek, CA 94598 US Other 510(k) Applications for this Company
Contact	Jash Bhayani Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/26/2021
Decision Date	08/04/2022
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