FDA 510(k) Application Details - K211512

Device Classification Name	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K211512
Device Name	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Applicant	Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 US Other 510(k) Applications for this Company
Contact	Leah Hawkins Other 510(k) Applications for this Contact
Regulation Number	888.3520   More FDA Info for this Regulation Number
Classification Product Code	HSX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/14/2021
Decision Date	09/16/2021
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