FDA 510(k) Application Details - K220274

Device Classification Name	More FDA Info for this Device
510(K) Number	K220274
Device Name	Kisar Stratford SI Screw System
Applicant	Anjali Investments L.L.C 1901 Cranbourne Rd Lutherville, MD 21093 US Other 510(k) Applications for this Company
Contact	Amit Patel 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	01/31/2022
Decision Date	04/24/2023
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