Endo-Model Standard Knee Prosthesis System 16-2011/22

GUDID 04026575222063

Sparepart Kit Boxes for Endo-Model SL

WALDEMAR LINK GmbH & Co. KG

Rotating hinged total knee prosthesis
Primary Device ID04026575222063
NIH Device Record Key6d85f800-09fb-4f9e-854f-06fd95265be1
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndo-Model Standard Knee Prosthesis System
Version Model Number16-2011/22
Catalog Number16-2011/22
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
GS104026575222063 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-23
Device Publish Date2021-08-13

On-Brand Devices [Endo-Model Standard Knee Prosthesis System]

04026575253647Tibial Plateau for Rotational Knee Prosthesis,Replacement Set
04026575253630Tibial Plateau for Rotational Knee Prosthesis,Replacement Set
04026575253623Tibial Plateau for Rotational Knee Prosthesis,Replacement Set
04026575214006Centralizer,Set consisting of small, medium, large
04026575205967Centralizer
04026575205950Centralizer
04026575205943Centralizer
04026575431632Tibial Plateau for Rotational Knee Prosthesis
04026575431625Tibial Plateau for Rotational Knee Prosthesis
04026575222933Sparepart Kit Boxes for Endo-Model SL
04026575222926Sparepart Kit Boxes for Endo-Model SL
04026575222230Sparepart Kit Boxes for Endo-Model SL
04026575222070Sparepart Kit Boxes for Endo-Model SL
04026575222063Sparepart Kit Boxes for Endo-Model SL
04026575222049Sparepart Kit Boxes for Endo-Model SL
04026575213429Tibial Plateau for Rotational Knee Prosthesis
04026575213221Tibial Plateau for Rotational Knee Prosthesis
04026575194698Replacement Set, with anti-luxation device
04026575194681Replacement Set, with anti-luxation device
04026575194674Replacement Set, with anti-luxation device
04026575194667Replacement Set, with anti-luxation device
04026575034710Rotational Knee Joint Prosthesis
04026575034703Rotational Knee Joint Prosthesis
04026575034697Rotational Knee Joint Prosthesis
04026575034680Rotational Knee Joint Prosthesis
04026575034673Rotational Knee Joint Prosthesis
04026575034666Rotational Knee Joint Prosthesis
04026575034659Rotational Knee Joint Prosthesis
04026575031016Rotational Knee Joint Prosthesis
04026575031009Rotational Knee Replacement Set
04026575030996Rotational Knee Replacement Set
04026575030095Rotational Knee Replacement Set
04026575026555Rotational Knee Replacement Set

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