LEGION HK AXLE SIZE 2 FEMUR

LEGION HK AXLE SIZE 2 FEMUR
LEGION - 71421933

A sterile implantable device designed to replace the patellofemoral and medial tibiofemoral articulating surfaces of a damaged/degenerative (e.g., arthritic) knee during primary or revision bicompartmental replacement of the joint; it is intended to permit retention of the lateral tibiofemoral compartment and both cruciate ligaments. The device is made of metal [e.g., oxidized zirconium alloy, cobalt-chrome (Co-Cr)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth; implantation is intended to be performed with bone cement.

• 6: 6

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 00885556108840

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