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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, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(k) Number K211742
Device Name SignaSure Dual Mobility System
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 Number888.3353
Classification Product Code
MEH  
Subsequent Product Code
LZO  
Date Received06/07/2021
Decision Date 01/07/2022
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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