FDA 510(k) Application Details - K250641

Device Classification Name	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K250641
Device Name	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
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	888.3110   More FDA Info for this Regulation Number
Classification Product Code	HSN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/04/2025
Decision Date	05/01/2025
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