Kinos Total Ankle Replacements

GUDID 00840097510774

Range Bearing Implant, Size 3, Left, 8mm

Restor3d, Inc.

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.

• 00840097512457 - Kinos Instrumentation: 2024-07-23 90 mm x 1.27 mm Sagittal Saw Blade, Conmed
• 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