Kinos Axiom Total Ankle Replacement

GUDID 00840097509228

X-Stem Implant, Standard, Size 3, Long with Tidal Technology

Restor3d, Inc.

Coated ankle tibia prosthesis

• Primary Device ID: 00840097509228
• NIH Device Record Key: 4963c6ea-9870-418d-80fb-9957d2f32260
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kinos Axiom Total Ankle Replacement
• Version Model Number: 1834-0031
• Company DUNS: 080819836
• Company Name: Restor3d, Inc.
• 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: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840097509228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232595

FDA Product Code

• HSN: Prosthesis, Ankle, Semi-Constrained, Cemented, 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: 2024-01-26
• Device Publish Date: 2024-01-18

On-Brand Devices [Kinos Axiom Total Ankle Replacement]

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• 00840097509235: X-Stem Implant, Tall, Size 3, Long with Tidal Technology
• 00840097509228: X-Stem Implant, Standard, Size 3, Long with Tidal Technology
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• 00840097509204: X-Stem Implant, Standard, Size 3, with Tidal Technology
• 00840097509198: X-Stem Implant, Tall, Size 2, with Tidal Technology
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• 00840097509174: X-Stem Implant, Tall, Size 1, with Tidal Technology
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