FDA 510(k) Applications Submitted by SIGNATURE ORTHOPAEDICS PTY LTD.

FDA 510(k) Number Submission Date Device Name Applicant
K160159 01/27/2016 Active-X Total Knee System Signature Orthopaedics Pty Ltd.
K220495 02/22/2022 SignaSure Dual Mobility System Signature Orthopaedics Pty Ltd.
K170613 03/01/2017 Genius Total Knee System Signature Orthopaedics Pty Ltd.
K190577 03/06/2019 World Knee Total Knee Systems Signature Orthopaedics Pty Ltd.
K220737 03/14/2022 World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC) Signature Orthopaedics Pty Ltd.
K190704 03/18/2019 Signature Ceramic Femoral Head Signature Orthopaedics Pty Ltd.
K180750 03/22/2018 World Knee System Signature Orthopaedics Pty Ltd.
K180754 03/22/2018 C-Zero Pedicle Screw System, Freedom Pedicle Screw System Signature Orthopaedics Pty Ltd.
K201047 04/21/2020 Fusion Taper System Signature Orthopaedics Pty Ltd.
K161155 04/25/2016 Origin Coxa Vara Hip Stem SIGNATURE ORTHOPAEDICS PTY LTD.
K181190 05/04/2018 Pinehurst Anterior Cervical Plate System Signature Orthopaedics Pty Ltd.
K201278 05/13/2020 World Hip Stem, World Cup, World Liner Signature Orthopaedics Pty Ltd.
K211505 05/14/2021 Encore Hip Stem Signature Orthopaedics Pty Ltd.
K181338 05/21/2018 Imboki Knee Instrument System Signature Orthopaedics Pty Ltd.
K181340 05/21/2018 Cemented TSI Hip Stem Signature Orthopaedics Pty Ltd.
K211742 06/07/2021 SignaSure Dual Mobility System Signature Orthopaedics Pty Ltd.
K181530 06/11/2018 World Total Knee System Signature Orthopaedics Pty Ltd.
K191708 06/26/2019 Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head Signature Orthopaedics Pty Ltd.
K172019 07/05/2017 Brisbane ALIF Device, Gladstone ALIF Device Signature Orthopaedics Pty Ltd.
K172020 07/05/2017 Arlington PLIF/TLIF Cage Signature Orthopaedics Pty Ltd.
K201951 07/13/2020 Cemented Origin Hip Stem Signature Orthopaedics Pty Ltd.
K192024 07/29/2019 Cemented TSI Hip Stem Signature Orthopaedics Pty Ltd.
K222380 08/05/2022 TriVerse Total Knee Replacement System Signature Orthopaedics Pty Ltd.
K212870 09/09/2021 TLC Unicompartmental Knee System Signature Orthopaedics Pty Ltd.
K223062 09/30/2022 World Total Knee System Signature Orthopaedics Pty Ltd.
K192883 10/10/2019 Spartan Hip Stem Signature Orthopaedics Pty Ltd.
K153131 10/30/2015 Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20░ Hooded Acetabular Liner SIGNATURE ORTHOPAEDICS PTY LTD.
K163081 11/03/2016 40-42mm BiPolar Head and 22mm Femoral Head SIGNATURE ORTHOPAEDICS PTY LTD.
K143184 11/05/2014 Evolve UniPolar Head Signature Orthopaedics Pty Ltd.
K163625 12/22/2016 NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System Signature Orthopaedics Pty Ltd.


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