FDA 510(k) Application Details - K202019

Device Classification Name	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K202019
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	Haylie Hertz 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	07/21/2020
Decision Date	01/14/2021
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