Waldemar Link GmbH & Co. KG
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 42
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250375 | Allure Hip Stem and Intramedullary Plugs | November 5, 2025 |
| K243927 | MobileLink Acetabular Cup System - inhouse coatings | May 16, 2025 |
| K241636 | MobileLink Acetabular Cup System - Line Extension (Multiple) | November 8, 2024 |
| K231445 | LINK Embrace Shoulder System - Reverse Configuration | November 16, 2023 |
| K222066 | LINK MobileLink Acetabular Cup System | April 14, 2023 |
| K230471 | LinkSymphoKnee Fixed Bearing Ultracongruent (FB UC) Articulating Surface | March 21, 2023 |
| K213770 | SP-CL Hip Stem and LCU Hip System | September 13, 2022 |
| K221794 | Vario-Cup System | July 20, 2022 |
| K211567 | BiMobile Instruments (for BiMobile Dual Mobility System) | June 3, 2022 |
| K220628 | LINK Endo-Model EVO Knee System | May 3, 2022 |
| K213675 | MP Reconstruction System | April 11, 2022 |
| K212992 | LINK® Embrace Shoulder System - Reverse Configuration | November 18, 2021 |
| K212742 | GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) in | September 16, 2021 |
| K211768 | LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE | June 30, 2021 |
| K210899 | LINK Embrace Shoulder System- Anatomical Configuration | June 21, 2021 |
| K200607 | LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters | May 28, 2021 |
| K202924 | LinkSymphoKnee System | May 13, 2021 |
| K200368 | LINK Embrace Shoulder System - Reverse Configuration | February 5, 2021 |
| K201364 | LINK TrabecuLink Femoral Cones | July 17, 2020 |
| K200113 | LINK TrabecuLink Tibial Cones | March 18, 2020 |