FDA 510(k) Application Details - K231496

Device Classification Name	More FDA Info for this Device
510(K) Number	K231496
Device Name	TITAN 3-D Wedge System
Applicant	Paragon 28 Inc 14445 Grasslands Drive Englewood, CO 80112 US Other 510(k) Applications for this Company
Contact	Haylie Hertz Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/24/2023
Decision Date	08/22/2023
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