FDA 510(k) Application Details - K234128

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K234128
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	Paragon 28, Inc. 14445 Grasslands Drive Englewood, CO 80112 US Other 510(k) Applications for this Company
Contact	Haylie Fast Other 510(k) Applications for this Contact
Regulation Number	888.3020   More FDA Info for this Regulation Number
Classification Product Code	HSB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/28/2023
Decision Date	08/22/2024
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