| Primary Device ID | 00810021869841 |
| NIH Device Record Key | 9c063037-9a80-454d-b7c2-feb1b5d3ab5c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoLink NeoFuse |
| Version Model Number | P20 ST201 |
| Catalog Number | P20 ST201 |
| Company DUNS | 079700711 |
| Company Name | IN2BONES USA, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810021869841 [Primary] |
| HRS | Plate, fixation, bone |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-20 |
| Device Publish Date | 2024-12-12 |
| 00810021869841 | CoLink NeoFuse MIS Plate, 3.5MM TALAR HOLES |
| 00810021867120 | CoLink NeoFuse MIS Plate, Standard |