FDA.report

510(k) K230471

Device
LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface
Applicant
Waldemar Link GmbH & Co. KG
510(k) number
K230471
Product code
JWH
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-21
Date received
2023-02-21
Regulation
888.3560
Classification name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Pia Muller
Address
Barkhausenweg 10 Hamburg DE 22339 22339

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
04026575533220LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533367LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533350LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533343LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533336LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533329LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533312LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533305LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533299LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533282LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533275LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533268LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533251LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533244LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533237LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533374LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533213LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533206LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533190LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533183LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533176LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533169LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533152LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533145LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533138LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533121LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533114LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533107LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533091LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26
04026575533060LinkSymphoKneeWALDEMAR LINK GmbH & Co. KG2023-04-26

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K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.2025-10-29
K253144Freedom® Total Knee System – Titan PCK ComponentsMaxx Orthopedics, Inc.2025-10-22
K252725Stem Extension Line (U2 Total Knee System—PSA Type)United Orthopedic Corporation2025-09-25
K251554Materialise TKA Guide SystemMaterialise NV2025-07-14
K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)Encore Medical L.P.2025-07-08
K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Encore Medical L.P.2025-07-02
K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc.2025-06-26
K242410NextStep Arthropedix Total Knee SystemNextstep Arthropedix2025-05-08
K250889EXULT Knee Replacement SystemCorentec Co., Ltd.2025-04-17
K250677LEGION Total Knee SystemSmith & Nephew, Inc.2025-04-02
K243991Klassic Knee System - Revision Tibial BaseplateTotal Joint Othopedics, Inc.2025-03-24