FDA 510(k) Application Details - K230563

Device Classification Name	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K230563
Device Name	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Applicant	MicroPort Orthopedics Inc. 5677 Airline Road Arlington, TN 38002 US Other 510(k) Applications for this Company
Contact	Ryan Ross Other 510(k) Applications for this Contact
Regulation Number	888.3510   More FDA Info for this Regulation Number
Classification Product Code	KRO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2023
Decision Date	09/27/2023
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