| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00840097510774 [Primary] |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-03 |
| Device Publish Date | 2024-06-25 |
| 00840097515236 - Kinos Total Ankle Instrumentation | 2025-06-24 X-Blade, Left |
| 00840097515243 - Kinos Total Ankle Instrumentation | 2025-06-24 X-Blade, Right |
| 00840097517735 - Kinos Total Ankle Instrumentation | 2025-06-24 Short X-Blade, Left |
| 00840097517742 - Kinos Total Ankle Instrumentation | 2025-06-24 Short X-Blade, Right |
| 00840097513744 - restor3d Anatomic Bone Model | 2025-05-30 Anatomic Bone Model |
| 00840097522708 - restor3d Guidewire | 2025-05-30 Guidewire, Single Trocar, 1.6mm x 5" |
| 00840097513782 - Ossera™ AFX | 2025-05-29 Cannulated Convex Reamer, Ø28 |
| 00840097517766 - Ossera™ AFX | 2025-05-29 Ossera™ AFX, Half Pill, 34x34 |