FDA 510(k) Application Details - K250001

Device Classification Name	More FDA Info for this Device
510(K) Number	K250001
Device Name	Patriot SI Implant System
Applicant	Spinal Simplicity LLC 6363 College Blvd Ste 320 Overland Park, KS 66211 US Other 510(k) Applications for this Company
Contact	Adam Rogers Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/2025
Decision Date	06/03/2025
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