FDA 510(k) Applications Submitted by Waldemar Link GmbH & Co. KG

FDA 510(k) Number Submission Date Device Name Applicant
K182872 10/12/2018 LINK GEMINI SL Total Knee System Waldemar Link GmbH & Co. KG
K183141 11/13/2018 LINK MP Monoblock Hip Prosthesis Waldemar Link GmbH & Co. KG
K151008 04/15/2015 LINK« MEGASYSTEM-C« Waldemar Link GmbH & Co. KG
K152431 08/26/2015 LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating WALDEMAR LINK GMBH & CO. KG
K143179 11/04/2014 The LINK« Endo-Model« Knee System Waldemar Link GmbH & Co. KG
K051826 07/05/2005 BETACONE HIP PROSTHESIS SYSTEM WALDEMAR LINK GMBH & CO. KG
K182321 08/27/2018 MobileLink Acetabular Cup System Waldemar Link GmbH & Co. KG
K192559 09/17/2019 Acetabular Bone Screws (for MobileLink Acetabular Cup System) Waldemar Link GmbH & Co. KG
K161840 07/05/2016 LINK« SP-CL« Hip System PoroLink« (microporous) and HX« (CaP) coated & LINK« LCU« Hip System PoroLink« (microporous) and HX« (CaP) coated Waldemar Link GmbH & Co. KG
K212742 08/30/2021 GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating Waldemar Link GmbH & Co. KG
K213770 12/02/2021 SP-CL Hip Stem and LCU Hip System Waldemar Link GmbH & Co. KG
K221794 06/21/2022 Vario-Cup System Waldemar Link GmbH & Co. KG
K230471 02/21/2023 LinkSymphoKnee û Fixed Bearing Ultracongruent (FB UC) Articulating Surface Waldemar Link GmbH & Co. KG
K200607 03/09/2020 LINK MobileLink« Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters Waldemar Link GmbH & Co. KG
K200113 01/17/2020 LINK TrabecuLink Tibial Cones Waldemar Link GmbH & Co. KG
K190535 03/04/2019 BiMobile Dual Mobility System - E-Dur Inserts Waldemar Link GmbH & Co. KG
K220628 03/04/2022 LINK Endo-Model EVO Knee System Waldemar Link GmbH & Co. KG
K210899 03/26/2021 LINK Embrace Shoulder System- Anatomical Configuration Waldemar Link GmbH & Co. KG
K211567 05/21/2021 BiMobile Instruments (for BiMobile Dual Mobility System) Waldemar Link GmbH & Co. KG
K201364 05/22/2020 LINK TrabecuLink Femoral Cones Waldemar Link GmbH & Co. KG
K211768 06/08/2021 LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE Waldemar Link GmbH & Co. KG
K191755 07/01/2019 SPAR-K Instruments (for use with Gemini SL Total Knee System) Waldemar Link GmbH & Co. KG
K212992 09/20/2021 LINK« Embrace Shoulder System - Reverse Configuration Waldemar Link GmbH & Co. KG
K202924 09/29/2020 LinkSymphoKnee System Waldemar Link GmbH & Co. KG
K171273 05/01/2017 LINK« BiMobile(TM) Dual Mobility System Waldemar Link Gmbh & Co. KG
K200368 02/14/2020 LINK Embrace Shoulder System - Reverse Configuration Waldemar Link GmbH & Co. KG
K142187 08/08/2014 LINK MP RECONSTRUCTION PROSTHESIS WALDEMAR LINK GMBH & CO. KG


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