| Primary Device ID | 08800039100212 |
| NIH Device Record Key | 5ce50f7b-6c58-4959-a651-6be28577527d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fixone Biocomposite Interference Screw |
| Version Model Number | IAB-80025a |
| Company DUNS | 963422810 |
| Company Name | AJU PHARM. CO., LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800039100212 [Primary] |
| HWC | Screw, 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 | 2025-01-14 |
| Device Publish Date | 2025-01-06 |
| 08800039101301 | The Fixone Biocomposite Interference Screws are intended to be used for fixation of bone-tendon- |
| 08800039101295 | The Fixone Biocomposite Interference Screws are intended to be used for fixation of bone-tendon- |
| 08800039101059 | The Fixone Biocomposite Interference Screws are intended to be used for fixation of bone-tendon- |
| 08800039100229 | The Fixone Biocomposite Interference Screws are intended to be used for fixation of bone-tendon- |
| 08800039100212 | The Fixone Biocomposite Interference Screws are intended to be used for fixation of bone-tendon- |