LINK Endo-Model EVO Knee System

GUDID 04026575274604

Replacement set, CoCrMo, UHMWPE, rotating hinge tibial plateau with plateau screw (EVO)

WALDEMAR LINK GmbH & Co. KG

Implantable orthopaedic/craniofacial device connection screw
Primary Device ID04026575274604
NIH Device Record Keyce561cf8-d24a-42f2-8831-311ba5fbdb3d
Commercial Distribution StatusIn Commercial Distribution
Brand NameLINK Endo-Model EVO Knee System
Version Model Number15-0037/19
Company DUNS315675488
Company NameWALDEMAR LINK GmbH & Co. KG
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104026575274604 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-06-09
Device Publish Date2023-01-26

On-Brand Devices [LINK Endo-Model EVO Knee System]

0402657530227715-0037/31
0402657530226015-0037/30
0402657529870915-3900/02
0402657527466615-9537/17
0402657527465915-9537/16
0402657527464215-9537/15
0402657527463515-9537/14
04026575274628Replacement set, CoCrMo, UHMWPE, rotating hinge tibial plateau with plateau screw (EVO)
04026575274611Replacement set, CoCrMo, UHMWPE, rotating hinge tibial plateau with plateau screw (EVO)
04026575274604Replacement set, CoCrMo, UHMWPE, rotating hinge tibial plateau with plateau screw (EVO)
04026575274598Replacement set, CoCrMo, UHMWPE, rotating hinge tibial plateau with plateau screw (EVO)
0402657518623515-3900/01

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