FDA 510(k) Application Details - K212431

Device Classification Name	Prosthesis, Hip, Femoral Component, Cemented, Metal   More FDA Info for this Device
510(K) Number	K212431
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	Gregory Foster 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	08/04/2021
Decision Date	02/07/2022
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