FDA 510(k) Application Details - K222653

Device Classification Name	Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer   More FDA Info for this Device
510(K) Number	K222653
Device Name	Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
Applicant	Smith+Nephew, Inc 1450 Brooks Rd Memphis, TN 38116 US Other 510(k) Applications for this Company
Contact	Lilian Hren Other 510(k) Applications for this Contact
Regulation Number	888.3535   More FDA Info for this Regulation Number
Classification Product Code	NJD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/01/2022
Decision Date	10/28/2022
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