| Primary Device ID | 00810111223737 |
| NIH Device Record Key | 50ca2306-e288-4aaf-8f50-d4d4786037de |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpeedPlate - SpeedAkin |
| Version Model Number | 02-00253 |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | 00810111223737 [Primary] |
| JDR | Staple, Fixation, Bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-04 |
| Device Publish Date | 2025-01-27 |
| 00810111223737 | Inserter Rod |
| 00810111223683 | Inserter Cap |