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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number K181340
Device Name Cemented TSI Hip Stem
Applicant
Signature Orthopaedics Pty, Ltd.
7 Sirius Rd.
Lane Cove West,  AU 2066
Applicant Contact Declan Brazil
Correspondent
Signature Orthopaedics Pty, Ltd.
7 Sirius Rd.
Lane Cove West,  AU 2066
Correspondent Contact Declan Brazil
Regulation Number888.3350
Classification Product Code
JDI  
Date Received05/21/2018
Decision Date 02/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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