FDA 510(k) Application Details - K123991

Device Classification Name	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented   More FDA Info for this Device
510(K) Number	K123991
Device Name	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Applicant	DEPUY FRANCE S.A.S. 700 ORTHOPAEDIC DRIVE WARSAW, IN 46581 US Other 510(k) Applications for this Company
Contact	ALMA RELJA, RAC Other 510(k) Applications for this Contact
Regulation Number	888.3390   More FDA Info for this Regulation Number
Classification Product Code	KWY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2012
Decision Date	09/16/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review