| 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 |
| 00840097532363 - Kinos Aeros Total Ankle Replacement | 2025-08-21 Aeros Locking Screw |
| 00840097512068 - restor3d Veritas rTSA Instrumentation | 2025-08-11 Humeral Cut Protector - Size S |
| 00840097512075 - restor3d Veritas rTSA Instrumentation | 2025-08-11 Humeral Cut Protector - Size M |
| 00840097512082 - restor3d Veritas rTSA Instrumentation | 2025-08-11 Reamer - Humeral Metaphysis -Small |
| 00840097512099 - restor3d Veritas rTSA Instrumentation | 2025-08-11 Inserter – Humeral Stem |
| 00840097512464 - restor3d Veritas rTSA Instrumentation | 2025-08-11 Humeral Cut Guide |
| 00840097512471 - restor3d Veritas rTSA Instrumentation | 2025-08-11 Tommy Bar |
| 00840097512488 - restor3d Veritas rTSA Instrumentation | 2025-08-11 Cartilage Scraper |