Alliant Biotech 22-01-02105

GUDID G6112201021050

Symmetric Total Knee Femoral Component Size 5 Right

MEDISURGE LLC

Coated knee femur prosthesis Coated knee femur prosthesis Coated knee femur prosthesis Coated knee femur prosthesis Coated knee femur prosthesis Coated knee femur prosthesis Coated knee femur prosthesis Coated knee femur prosthesis Coated knee femur prosthesis Coated knee femur prosthesis Coated knee femur prosthesis Coated knee femur prosthesis Coated knee femur prosthesis Coated knee femur prosthesis Coated knee femur prosthesis

• Primary Device ID: G6112201021050
• NIH Device Record Key: db3df09b-abfd-41e8-ac53-d3867805a890
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alliant Biotech
• Version Model Number: 5RT
• Catalog Number: 22-01-02105
• Company DUNS: 119198202
• Company Name: MEDISURGE 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8883071144
• Email: mmorrissey@medisurge.com
• Phone: 8883071144
• Email: mmorrissey@medisurge.com
• Phone: 8883071144
• Email: mmorrissey@medisurge.com
• Phone: 8883071144
• Email: mmorrissey@medisurge.com
• Phone: 8883071144
• Email: mmorrissey@medisurge.com
• Phone: 8883071144
• Email: mmorrissey@medisurge.com
• Phone: 8883071144
• Email: mmorrissey@medisurge.com
• Phone: 8883071144
• Email: mmorrissey@medisurge.com
• Phone: 8883071144
• Email: mmorrissey@medisurge.com
• Phone: 8883071144
• Email: mmorrissey@medisurge.com
• Phone: 8883071144
• Email: mmorrissey@medisurge.com
• Phone: 8883071144
• Email: mmorrissey@medisurge.com
• Phone: 8883071144
• Email: mmorrissey@medisurge.com
• Phone: 8883071144
• Email: mmorrissey@medisurge.com
• Phone: 8883071144
• Email: mmorrissey@medisurge.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G6112201021050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080199

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-17
• Device Publish Date: 2024-05-09

On-Brand Devices [Alliant Biotech]

• G611220811261500: Symmetric Total Knee Coated Revision Stem Size 26x150
• G6112203013550: Symmetric Total Knee Ultracongruent Tibial Insert Size 5x35
• G6112203013050: Symmetric Total Knee Ultracongruent Tibial Insert Size 5x30
• G6112203011870: Symmetric Total Knee Ultracongruent Tibial Insert Size 7x18
• G6112203002070: Symmetric Total Knee Standard Tibial Insert Size 7x20
• G6112203001870: Symmetric Total Knee Standard Tibial Insert Size 7x18
• G6112203001460: Symmetric Total Knee Standard Tibial Insert Size 6x14
• G61122021260: Symmetric Total Knee Tibial Tray Size 6
• G6112201021050: Symmetric Total Knee Femoral Component Size 5 Right
• G6112201020050: Symmetric Total Knee Femoral Component Size 5 Left