FDA 510(k) Application Details - K181340

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented   More FDA Info for this Device
510(K) Number	K181340
Device Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Applicant	Signature Orthopaedics Pty Ltd. 7 Sirius Road Lane Cove 2066 AU Other 510(k) Applications for this Company
Contact	Declan Brazil Other 510(k) Applications for this Contact
Regulation Number	888.3350   More FDA Info for this Regulation Number
Classification Product Code	JDI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/21/2018
Decision Date	02/11/2019
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