| Primary Device ID | 00810111223515 |
| NIH Device Record Key | e4876a8d-351f-46fb-904f-2c588a75954a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpeedMTP Compression Screws |
| Version Model Number | SK60 |
| Company DUNS | 054808082 |
| Company Name | Treace Medical Concepts, 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 | true |
| 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 | 00810111223515 [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 | 2024-11-14 |
| Device Publish Date | 2024-11-06 |
| 00810111223515 - SpeedMTP Compression Screws | 2024-11-14Headless Compression Screws |
| 00810111223515 - SpeedMTP Compression Screws | 2024-11-14 Headless Compression Screws |
| 00810111222693 - Ratchet Handle | 2024-11-08 Ratchet Handle |
| 00810111222846 - Guide Sleeve | 2024-11-08 Screw Sleeve |
| 00810111222853 - Guide Sleeve | 2024-11-08 Parallel Guide |
| 00810111222860 - Elevator | 2024-11-08 Head Shifter |
| 00810111222877 - Length Gage | 2024-11-08 Length Gage |
| 00810111222990 - Drill | 2024-11-08 Drill, Cannulated |
| 00810111223003 - Drill | 2024-11-08 Drill, Cannulated |