FDA.report

510(k) K222066

Device
LINK MobileLink Acetabular Cup System
Applicant
Waldemar Link GmbH & Co. KG
510(k) number
K222066
Product code
LPH
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-14
Date received
2022-07-13
Regulation
888.3358
Classification name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Stefanie Fuchs
Address
Oststrasse 4-10 Norderstedt DE 22844 22844

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
04026575175925MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575175772MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575175789MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575175796MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575175802MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575175819MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575175826MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575175833MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575175840MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575175857MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575175864MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575175871MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575175888MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575175895MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575175901MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575175918MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575176243MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575176090MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575176106MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575176113MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575176120MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575176137MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575176144MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575176151MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575176168MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575176175MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575176182MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575176199MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575176205MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18
04026575176212MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KG2023-04-18

Other 510(k) Records For Product Code LPH

510(k)DeviceApplicantDecision date
K252623G7® Revision Acetabular SystemZimmer, Inc.2026-02-04
K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.2026-01-28
K252067Velora Acetabular SystemRestor3D, Inc.2025-12-05
K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics2025-11-20
K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.2025-11-12
K251718ArTT Augments and Buttresses and Bone ScrewsLima Corporate S.P.A.2025-08-29
K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)2025-07-25
K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.2025-06-06
K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited2025-06-05
K242232Mpact 3D Metal Augments IIMedacta International S.A.2025-04-23
K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.2025-04-10
K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics2025-02-06
K243977EMPHASYS Acetabular SystemDepuy Ireland UC2025-01-22
K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A2025-01-13
K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG2024-11-08