FDA 510(k) Application Details - K240594

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K240594
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	Paragon 28, Inc. 14445 Grasslands Dr. Englewood, CO 80112 US Other 510(k) Applications for this Company
Contact	Edward Wells-Spicer Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	MBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/04/2024
Decision Date	03/26/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review