Alliant Biotech 22-04-03045

GUDID G6112204030450

Symmetric Total Knee Patellar Button Size 30/45

MEDISURGE LLC

Polyethylene patella prosthesis

• Primary Device ID: G6112204030450
• NIH Device Record Key: 38025de5-c77e-47f0-b817-83ec7bd0552a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alliant Biotech
• Version Model Number: 30/45
• Catalog Number: 22-04-03045
• 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
• Phone: 8883071144
• Email: mmorrissey@medisurge.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G6112204030450 [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: 2024-08-12
• Device Publish Date: 2024-08-02

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• 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
• G611WF110070: Cancellous Bone Screw Size 6.5mm x 45mm
• G61122051024650: Symmetric Total Knee Metaphyseal Stem Size 24x65
• G61122051022600: Symmetric Total Knee Metaphyseal Stem Size 22x60
• G6112203012540: Symmetric Total Knee Ultracongruent Tibial Insert Size 4x25
• G6112203011840: Symmetric Total Knee Ultracongruent Tibial Insert Size 4x18
• G6112203011440: Symmetric Total Knee Ultracongruent Tibial Insert Size 4x14
• G6112203011250: Symmetric Total Knee Ultracongruent Tibial Insert Size 5x12
• G6112203001650: Symmetric Total Knee Standard Tibial Insert Size 5x16
• G6112203001450: Symmetric Total Knee Standard Tibial Insert Size 5x14
• G6112201020040: Symmetric Total Knee Femoral Component Size 4 Left
• G6112201020030: Symmetric Total Knee Femoral Component Size 3 Left
• G6112201021070: Symmetric Total Knee Femoral Component Size 7 Right
• G6112201021060: Symmetric Total Knee Femoral Component Size 6 Right
• G6112201021040: Symmetric Total Knee Femoral Component Size 4 Right
• G6112201021030: Symmetric Total Knee Femoral Component Size 3 Right
• G6112201020070: Symmetric Total Knee Femoral Component Size 7 Left
• G6112201020060: Symmetric Total Knee Femoral Component Size 6 Left
• G61122021270: Symmetric Total Knee Tibial Tray Size 7
• G61122021250: Symmetric Total Knee Tibial Tray Size 5
• G61122021240: Symmetric Total Knee Tibial Tray Size 4
• G61122021230: Symmetric Total Knee Tibial Tray Size 3
• G6112203001470: Symmetric Total Knee Standard Tibial Insert Size 7x14
• G6112203001440: Symmetric Total Knee Standard Tibial Insert Size 4x14
• G6112203001430: Symmetric Total Knee Standard Tibial Insert Size 3x14
• G6112203001270: Symmetric Total Knee Standard Tibial Insert Size 7x12
• G6112203001260: Symmetric Total Knee Standard Tibial Insert Size 6x12
• G6112203001250: Symmetric Total Knee Standard Size 5x12
• G6112203001240: Symmetric Total Knee Standard Tibial Insert Size 4x12
• G6112203001230: Symmetric Total Knee Standard Tibial Insert Size 3x12
• G6112203001070: Symmetric Total Knee Standard Tibial Insert Size 7x10
• G6112203001060: Symmetric Total Knee Standard Tibial Insert Size 6x10
• G6112203001050: Symmetric Total Knee Standard Tibial Insert Size 5x10
• G6112203001040: Symmetric Total Knee Standard Tibial Insert Size 4x10
• G6112203001030: Symmetric Total Knee Standard Tibial Insert Size 3x10
• G6112203011070: Symmetric Total Knee Ultracongruent Tibial Insert Size 7x10
• G6112203011060: Symmetric Total Knee Ultracongruent Tibial Insert Size 6x10
• G6112203011050: Symmetric Total Knee Ultracongruent Tibial Insert Size 5x10
• G6112203011040: Symmetric Total Knee Ultracongruent Tibial Insert Size 4x10
• G6112203011030: Symmetric Total Knee Ultracongruent Tibial Insert Size 3x10
• G6112203002060: Symmetric Total Knee Standard Tibial Insert Size 6x20