PROFIX HA POROUS TIBIALBASE SZ 6 LT

PROFIX HA POROUS TIBIALBASE SZ 6 LT
PROFIX - 71505260

A sterile implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr)] and is coated with a material (e.g., beads, hydroxyapatite, mesh) intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with an insert and the femoral prosthetic component of the knee joint and its implantation may be performed with or without bone cement.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MBH

Device Name: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/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: 888.3565

Third Party Flag: N

Medical Specialty: OR

Device Id: 03596010484840

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