FDA 510(k) Application Details - K250952

Device Classification Name	More FDA Info for this Device
510(K) Number	K250952
Device Name	Baby Gorilla«/Gorilla« Plating System
Applicant	Paragon 28 Inc 14445 Grasslands Drive Englewood, CO 80112 US Other 510(k) Applications for this Company
Contact	Edward Wells-Spicer Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2025
Decision Date	07/18/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review