FDA.report

Endo-Model Modular Knee Prosthesis System

Primary DI
04026575325849
Brand
Endo-Model Modular Knee Prosthesis System
Company
WALDEMAR LINK GmbH & Co. KG
Model
15-2951/06
Catalog number
15-2951/06
Device description
Modular Stem,Cylindrical
Published
2015-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Product Code Classifications

CodeDeviceSpecialtyClass
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026575325849PrimaryGS10

GMDN Terms

TermDefinition
Knee femur stem prosthesisA sterile device designed to provide additional stability for an implanted knee femur prosthesis by extending the attachment of the prosthesis from the distal femur into the midshaft of the bone. It is typically a shaft-like device made of metal [e.g., cobalt-chrome (Co-Cr)] and is often used in prosthesis revision to compensate for bone loss.

Sterilization Methods

Method

Regulatory Flags

DUNS number
315675488
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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