FDA 510(k) Application Details - K193546

Device Classification Name	Prosthesis, Hip, Femoral Component, Cemented, Metal   More FDA Info for this Device
510(K) Number	K193546
Device Name	Prosthesis, Hip, Femoral Component, Cemented, Metal
Applicant	Biomet Inc. 56 East Bell Drive, PO Box 587 Warsaw, IN 46581 US Other 510(k) Applications for this Company
Contact	Jessica Andreshak Other 510(k) Applications for this Contact
Regulation Number	888.3360   More FDA Info for this Regulation Number
Classification Product Code	JDG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2019
Decision Date	09/25/2020
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