FDA 510(k) Application Details - K192778

Device Classification Name	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K192778
Device Name	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Applicant	Kinos Medical 992 Old Eagle School Road Suite 907 Wayne, PA 19087 US Other 510(k) Applications for this Company
Contact	Brian Garvey 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	09/30/2019
Decision Date	06/30/2020
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