FDA 510(k) Application Details - K193029

Device Classification Name	Device, Fixation, Proximal Femoral, Implant   More FDA Info for this Device
510(K) Number	K193029
Device Name	Device, Fixation, Proximal Femoral, Implant
Applicant	Smith & Nephew, Inc. 1450 E Brooks Rd Memphis, TN 38116 US Other 510(k) Applications for this Company
Contact	Thomas Fearnley Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	JDO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/30/2019
Decision Date	02/28/2020
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