FDA 510(k) Application Details - K244039

Device Classification Name	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer   More FDA Info for this Device
510(K) Number	K244039
Device Name	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Applicant	Suzhou MicroPort OrthoRecon Co., Ltd. Building 2 and 3, NO.151, Fengli Street, Suzhou Industrial Park Pilot Free Trade Zone Suzhou District Suzhou 215000 CN Other 510(k) Applications for this Company
Contact	Qingling Bao Other 510(k) Applications for this Contact
Regulation Number	888.3560   More FDA Info for this Regulation Number
Classification Product Code	JWH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/2024
Decision Date	02/28/2025
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