Modal Total Knee System

GUDID B035M331120511

PS Tibial Trial Insert Size 1 18mm

MODAL MANUFACTURING LLC

Knee tibia prosthesis trial

• Primary Device ID: B035M331120511
• NIH Device Record Key: 9f048e8c-7bcd-4b91-90f3-bc4045646dfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Modal Total Knee System
• Version Model Number: M-3311-2051
• 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	B035M331120511 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142649

FDA Product Code

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

Sterilization

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

[B035M331120511]

Moist Heat or Steam Sterilization

[B035M331120511]

Moist Heat or Steam Sterilization

[B035M331120511]

Moist Heat or Steam Sterilization

[B035M331120511]

Moist Heat or Steam Sterilization

[B035M331120511]

Moist Heat or Steam Sterilization

[B035M331120511]

Moist Heat or Steam Sterilization

[B035M331120511]

Moist Heat or Steam Sterilization

[B035M331120511]

Moist Heat or Steam Sterilization

[B035M331120511]

Moist Heat or Steam Sterilization

[B035M331120511]

Moist Heat or Steam Sterilization

[B035M331120511]

Moist Heat or Steam Sterilization

[B035M331120511]

Moist Heat or Steam Sterilization

[B035M331120511]

Moist Heat or Steam Sterilization

[B035M331120511]

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: 2018-06-01

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