FDA 510(k) Application Details - K192994

Device Classification Name	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K192994
Device Name	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Applicant	Paragon 28, Inc. 4B Inverness Ct. E., STE 280 Englewood, CO 80112 US Other 510(k) Applications for this Company
Contact	Eric Lintula 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	10/25/2019
Decision Date	07/10/2020
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