FDA.reportPublic FDA data

510(k) K241636

Device
MobileLink Acetabular Cup System - Line Extension (Multiple)
Applicant
Waldemar Link GmbH & Co. KG
510(k) number
K241636
Product code
LPH
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-08
Date received
2024-06-06
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
No

Applicant Contact#

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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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