DEVICE: Endo-Model Standard Knee Prosthesis System (04026575047987)

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Device Identifier (DI) Information

Endo-Model Standard Knee Prosthesis System
15-8022/11
15-8022/11
WALDEMAR LINK GmbH & Co. KG
04026575047987
GS1
1
Rotational Knee Joint Prosthesis,with anti-luxation device
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Rotating hinged total knee prosthesis A sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the joint [total knee arthroplasty (TKA)] because of major loss of stabilizing structures or bone around the knee, often from tumour resection, or to replace a dysfunctional knee prosthesis (revision); it is designed with a mechanism for joint rotation and its major components are connected for stability typically about a transverse axis posterior of the rotational axis. It typically includes femoral, tibial, and patellar components that articulate and with parts made of metal, ceramic, and/or polyethylene (PE); it may be implated with or without bone cement.
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FDA Product Code

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Product Code Product Code Name
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
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Sterilization

Yes
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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
November 01, 2015

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
None
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Production Identifier(s) in UDI

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Yes
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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