restor3d Kinos Axiom Total Ankle System

GUDID 00840097505091

Tibial Implant, Size 4, Left, with Tidal Technology

Restor3d, Inc.

Fixed-bearing total ankle prosthesis

• Primary Device ID: 00840097505091
• NIH Device Record Key: 9235c785-5f95-4fbb-ac82-b83d4c650db4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: restor3d Kinos Axiom Total Ankle System
• Version Model Number: 1831.1140
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840097505091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192778

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-11-02
• Device Publish Date: 2022-12-29

On-Brand Devices [restor3d Kinos Axiom Total Ankle System]

• 00840097505206: Tibial Implant, Size 5, Long Right, with Tidal Technology
• 00840097505190: Tibial Implant, Size 5, Right, with Tidal Technology
• 00840097505183: Tibial Implant, Size 4, Long Right, with Tidal Technology
• 00840097505176: Tibial Implant, Size 4, Right, with Tidal Technology
• 00840097505169: Tibial Implant, Size 3, Long Right, with Tidal Technology
• 00840097505152: Tibial Implant, Size 3, Right, with Tidal Technology
• 00840097505145: Tibial Implant, Size 2, Right, with Tidal Technology
• 00840097505138: Tibial Implant, Size 1, Right, with Tidal Technology
• 00840097505121: Tibial Implant, Size 5, Long Left, with Tidal Technology
• 00840097505114: Tibial Implant, Size 5, Left, with Tidal Technology
• 00840097505107: Tibial Implant, Size 4, Long Left, with Tidal Technology
• 00840097505091: Tibial Implant, Size 4, Left, with Tidal Technology
• 00840097505084: Tibial Implant, Size 3, Long Left, with Tidal Technology
• 00840097505077: Tibial Implant, Size 3, Left, with Tidal Technology
• 00840097505060: Tibial Implant, Size 2, Left, with Tidal Technology
• 00840097505053: Tibial Implant, Size 1, Left, with Tidal Technology