FDA 510(k) Application Details - K122853

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate   More FDA Info for this Device
510(K) Number	K122853
Device Name	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
Applicant	HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. MAHWAH, NJ 07430 US Other 510(k) Applications for this Company
Contact	VALERIE GIAMBANCO Other 510(k) Applications for this Contact
Regulation Number	888.3353   More FDA Info for this Regulation Number
Classification Product Code	MEH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/18/2012
Decision Date	02/01/2013
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