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Waldemar Link GmbH & Co. KG

FDA 510(k) & PMA Approved Devices — 30 products

Total Devices30
Categories9
Latest FDA decision2026-07-06
TypeNumberDevice NameCodeDateActions
510(k) K261009 MobileLink Acetabular Cup System – 40mm ID Inserts (various)LZO2026-07-06 View
510(k) K250375 Allure Hip Stem and Intramedullary PlugsMEH2025-11-05 View
510(k) K243927 MobileLink Acetabular Cup System - inhouse coatingsLZO2025-05-16 View
510(k) K241636 MobileLink Acetabular Cup System - Line Extension (Multiple)LPH2024-11-08 View
510(k) K231445 LINK Embrace Shoulder System - Reverse ConfigurationPHX2023-11-16 View
510(k) K222066 LINK MobileLink Acetabular Cup SystemLPH2023-04-14 View
510(k) K230471 LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceJWH2023-03-21 View
510(k) K213770 SP-CL Hip Stem and LCU Hip SystemLZO2022-09-13 View
510(k) K221794 Vario-Cup SystemKWY2022-07-20 View
510(k) K211567 BiMobile Instruments (for BiMobile Dual Mobility System)LZO2022-06-03 View
510(k) K220628 LINK Endo-Model EVO Knee SystemKRO2022-05-03 View
510(k) K213675 MP Reconstruction SystemLZO2022-04-11 View
510(k) K212992 LINK® Embrace Shoulder System - Reverse ConfigurationPHX2021-11-18 View
510(k) K212742 GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coatingJWH2021-09-16 View
510(k) K211768 LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPEKRO2021-06-30 View
510(k) K210899 LINK Embrace Shoulder System- Anatomical ConfigurationKWT2021-06-21 View
510(k) K200607 LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersLPH2021-05-28 View
510(k) K202924 LinkSymphoKnee SystemJWH2021-05-13 View
510(k) K200368 LINK Embrace Shoulder System - Reverse ConfigurationPHX2021-02-05 View
510(k) K201364 LINK TrabecuLink Femoral ConesMBH2020-07-17 View

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