LEGION HINGE HYPEREXTENSION STOP WITH AXLE PLUGS


Product Overview

LEGION HINGE HYPEREXTENSION STOP WITH AXLE PLUGS
LEGION - 71421648


Device Description

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.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: KRO

Device Name: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 888.3510

Third Party Flag: N

Medical Specialty: OR


Device Identifiers

Device Id: 00885556030509

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


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