FDA 510(k) Application Details - K133370

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented   More FDA Info for this Device
510(K) Number	K133370
Device Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Applicant	SIGNATURE ORTHOPAEDICS PTY LIMITED 7 Sirius Road LANE COVE NSW 2066 AU Other 510(k) Applications for this Company
Contact	DECLAN BRAZIL Other 510(k) Applications for this Contact
Regulation Number	888.3358   More FDA Info for this Regulation Number
Classification Product Code	LPH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/04/2013
Decision Date	07/22/2014
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