Kinos Axiom Total Ankle Replacement

GUDID 00840097509204

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

Restor3d, Inc.

Coated ankle tibia prosthesis Coated ankle tibia prosthesis Coated ankle tibia prosthesis Coated ankle tibia prosthesis Coated ankle tibia prosthesis Coated ankle tibia prosthesis Coated ankle tibia prosthesis Coated ankle tibia prosthesis Coated ankle tibia prosthesis Coated ankle tibia prosthesis Coated ankle tibia prosthesis Coated ankle tibia prosthesis Coated ankle tibia prosthesis Coated ankle tibia prosthesis Coated ankle tibia prosthesis Coated ankle tibia prosthesis Coated ankle tibia prosthesis

• Primary Device ID: 00840097509204
• NIH Device Record Key: 066d97e0-ed80-4653-9f48-0e6fee6e2151
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kinos Axiom Total Ankle Replacement
• Version Model Number: 1834-0030
• 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	00840097509204 [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

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