JII BCS TRIAL INSERT 7-8 10MM R

JII BCS TRIAL INSERT 7
JII - E0016482-14

An 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 entirely of polyethylene (PE) and is not coated with a material 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 is intended to be performed with bone cement.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Moist Heat or Steam Sterilization

Code: JWH

Device Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, 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: 888.3560

Third Party Flag: N

Medical Specialty: OR

Device Id: 00885556755426

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