Modal Total Knee System

GUDID B035M311111021

Size 2 Left Femoral Trial CR

MODAL MANUFACTURING LLC

Knee femur prosthesis trial Knee femur prosthesis trial Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable

• Primary Device ID: B035M311111021
• NIH Device Record Key: 9daab4bb-cd37-4db3-b7b9-4aa6ae50b600
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Modal Total Knee System
• Version Model Number: M-3111-1102
• Company DUNS: 081983825
• Company Name: MODAL MANUFACTURING LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B035M311111021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150783

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[B035M311111021]

Moist Heat or Steam Sterilization

[B035M311111021]

Moist Heat or Steam Sterilization

[B035M311111021]

Moist Heat or Steam Sterilization

[B035M311111021]

Moist Heat or Steam Sterilization

[B035M311111021]

Moist Heat or Steam Sterilization

[B035M311111021]

Moist Heat or Steam Sterilization

[B035M311111021]

Moist Heat or Steam Sterilization

[B035M311111021]

Moist Heat or Steam Sterilization

[B035M311111021]

Moist Heat or Steam Sterilization

[B035M311111021]

Moist Heat or Steam Sterilization

[B035M311111021]

Moist Heat or Steam Sterilization

[B035M311111021]

Moist Heat or Steam Sterilization

[B035M311111021]

Moist Heat or Steam Sterilization

[B035M311111021]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-04-30

On-Brand Devices [Modal Total Knee System]

• B035M342050071: Patellar Drill Guide 38mm
• B035M342050061: Patellar Drill Guide 35mm
• B035M342050051: Patellar Drill Guide 32mm
• B035M342050041: Patellar Drill
• B035M342050031: Patellar Cement Clamp
• B035M342050021: Patellar Drill Guide 29mm
• B035M342050011: Patellar Drill & Cement Clamp
• B035M342050001: Patellar Resection Clamp
• B035M341100901: Patella Trial 38mm
• B035M341100801: Patella Trial 35mm
• B035M341100701: Patella Trial 32mm
• B035M341100601: Patella Trial 29mm
• B035M340100901: Patella 38mm
• B035M340100801: Patella 35mm
• B035M340100701: Patella 32mm
• B035M340100601: Patella 29mm
• B035M332050001: Tibial Insert Impactor
• B035M331140561: UC CR Tibial Trial Insert Size 6 - 18mm
• B035M331140551: UC CR Tibial Trial Insert Size 5 - 18mm
• B035M331140541: UC CR Tibial Trial Insert Size 4 - 18mm
• B035M331140531: UC CR Tibial Trial Insert Size 3 - 18mm
• B035M331140521: UC CR Tibial Trial Insert Size 2 - 18mm
• B035M331140511: UC CR Tibial Trial Insert Size 1 - 18mm
• B035M331140461: UC CR Tibial Trial Insert Size 6 - 15mm
• B035M331140451: UC CR Tibial Trial Insert Size 5 - 15mm
• B035M331140441: UC CR Tibial Trial Insert Size 4 - 15mm
• B035M331140431: UC CR Tibial Trial Insert Size 3 - 15mm
• B035M331140421: UC CR Tibial Trial Insert Size 2 - 15mm
• B035M331140411: UC CR Tibial Trial Insert Size 1 - 15mm
• B035M331140361: UC CR Tibial Trial Insert Size 6 - 13mm
• B035M331140351: UC CR Tibial Trial Insert Size 5 - 13mm
• B035M331140341: UC CR Tibial Trial Insert Size 4 - 13mm
• B035M331140331: UC CR Tibial Trial Insert Size 3 - 13mm
• B035M331140321: UC CR Tibial Trial Insert Size 2 - 13mm
• B035M331140311: UC CR Tibial Trial Insert Size 1 - 13mm
• B035M331140261: UC CR Tibial Trial Insert Size 6 - 11mm
• B035M331140251: UC CR Tibial Trial Insert Size 5 - 11mm
• B035M331140241: UC CR Tibial Trial Insert Size 4 - 11mm
• B035M331140231: UC CR Tibial Trial Insert Size 3 - 11mm
• B035M331140221: UC CR Tibial Trial Insert Size 2 - 11mm
• B035M331140211: UC CR Tibial Trial Insert Size 1 - 11mm
• B035M331140161: UC CR Tibial Trial Insert Size 6 - 9mm
• B035M331140151: UC CR Tibial Trial Insert Size 5 - 9mm
• B035M331140141: UC CR Tibial Trial Insert Size 4 - 9mm
• B035M331140131: UC CR Tibial Trial Insert Size 3 - 9mm
• B035M331140121: UC CR Tibial Trial Insert Size 2 - 9mm
• B035M331140111: UC CR Tibial Trial Insert Size 1 - 9mm
• B035M331120561: PS Tibial Trial Insert Size 6 18mm
• B035M331120551: PS Tibial Trial Insert Size 5 18mm
• B035M331120541: PS Tibial Trial Insert Size 4 18mm