FDA 510(k) Application Details - K231448

Device Classification Name	Prosthesis, Hip, Hemi-, Femoral, Metal Ball   More FDA Info for this Device
510(K) Number	K231448
Device Name	Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Applicant	Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 US Other 510(k) Applications for this Company
Contact	Nikita Deshpande Other 510(k) Applications for this Contact
Regulation Number	888.3360   More FDA Info for this Regulation Number
Classification Product Code	LZY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/18/2023
Decision Date	07/19/2023
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