| Primary Device ID | 00810111224468 |
| NIH Device Record Key | 7ef1b08a-24f9-4623-b2fd-aa9030f8d74c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Corner Chisel |
| Version Model Number | 02-00327 |
| Company DUNS | 054808082 |
| Company Name | Treace Medical Concepts, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 | 00810111224468 [Primary] |
| FZO | Chisel, Surgical, Manual |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810111224468]
Moist Heat or Steam Sterilization
[00810111224468]
Moist Heat or Steam Sterilization
[00810111224468]
Moist Heat or Steam Sterilization
[00810111224468]
Moist Heat or Steam Sterilization
[00810111224468]
Moist Heat or Steam Sterilization
[00810111224468]
Moist Heat or Steam Sterilization
[00810111224468]
Moist Heat or Steam Sterilization
[00810111224468]
Moist Heat or Steam Sterilization
[00810111224468]
Moist Heat or Steam Sterilization
[00810111224468]
Moist Heat or Steam Sterilization
[00810111224468]
Moist Heat or Steam Sterilization
[00810111224468]
Moist Heat or Steam Sterilization
[00810111224468]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-02 |
| Device Publish Date | 2025-03-25 |
| 00810111224918 - TMC FastPitch Screws | 2025-12-22 Locking Screws |
| 00810111225175 - TMC SpeedTMT | 2025-12-22 Inserter Cap |
| 00810111225199 - TMC SpeedTMT | 2025-12-22 Rapid Compression Implants |
| 00810111225373 - TMC SpeedTMT | 2025-12-22 Inserter Rod |
| 00810111225151 - Drill Guide | 2025-12-04 Drill Guide and Template |
| 00810111225311 - K-Wire | 2025-11-28 Percuplasty 1.6 x 152mm K-Wire |
| 00810111225328 - K-Wire | 2025-11-28 Percuplasty 1.4 x 152mm K-wire |
| 00810111224857 - TMC SpeedMTP | 2025-11-24 Rapid Compression Implants |