FDA.report

510(k) K182872

Device
LINK GEMINI SL Total Knee System
Applicant
Waldemar Link GmbH & Co. KG
510(k) number
K182872
Product code
JWH  
Decision
Substantially Equivalent (SESE)
Decision date
2019-04-03
Date received
2018-10-12
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
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Andre von Malotki
Address
Oststrabe 4-1 0 Norderstedt DE 22844 22844

FDA Registration Numbers

Source Documents

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

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