Kinos Total Ankle Replacements

GUDID 00840097510774

Range Bearing Implant, Size 3, Left, 8mm

Restor3d, Inc.

Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing

• Primary Device ID: 00840097510774
• NIH Device Record Key: 18f15788-ba69-4cca-b6ab-a2f0aacc3193
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kinos Total Ankle Replacements
• Version Model Number: 3832-1308
• 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: true
• 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	00840097510774 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240591

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: 2024-07-03
• Device Publish Date: 2024-06-25

Devices Manufactured by Restor3d, Inc.

• 00840097510453 - Kinos Total Ankle Replacement: 2024-07-04 Range Chamfer Talar Implant, Size 2, Left, with Tidal Technology
• 00840097510460 - Kinos Total Ankle Replacement: 2024-07-04 Range Chamfer Talar Implant, Size 3, Left, with Tidal Technology
• 00840097510477 - Kinos Total Ankle Replacement: 2024-07-04 Range Chamfer Talar Implant, Size 4, Left, with Tidal Technology
• 00840097510484 - Kinos Total Ankle Replacement: 2024-07-04 Range Chamfer Talar Implant, Size 0, Right, with Tidal Technology
• 00840097510491 - Kinos Total Ankle Replacement: 2024-07-04 Range Chamfer Talar Implant, Size 1, Right, with Tidal Technology
• 00840097510507 - Kinos Total Ankle Replacement: 2024-07-04 Range Chamfer Talar Implant, Size 2, Right, with Tidal Technology
• 00840097510514 - Kinos Total Ankle Replacement: 2024-07-04 Range Chamfer Talar Implant, Size 3, Right, with Tidal Technology
• 00840097510521 - Kinos Total Ankle Replacement: 2024-07-04 Range Chamfer Talar Implant, Size 4, Right, with Tidal Technology