| Primary Device ID | 00810111222679 |
| NIH Device Record Key | 374db443-eebb-4245-8653-d66d78c0d658 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Broach |
| Version Model Number | 02-00179 |
| 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 | false |
| 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 | 00810111222679 [Primary] |
| HTQ | Broach |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810111222679]
Moist Heat or Steam Sterilization
[00810111222679]
Moist Heat or Steam Sterilization
[00810111222679]
Moist Heat or Steam Sterilization
[00810111222679]
Moist Heat or Steam Sterilization
[00810111222679]
Moist Heat or Steam Sterilization
[00810111222679]
Moist Heat or Steam Sterilization
[00810111222679]
Moist Heat or Steam Sterilization
[00810111222679]
Moist Heat or Steam Sterilization
[00810111222679]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-14 |
| Device Publish Date | 2025-08-06 |
| 00810111225366 - Saw Blade | 2026-02-03 Dorsal Akin Saw Blade - ZMS |
| 00810111225236 - Lapiplasty SpeedPlate - TMT | 2026-02-02 Locking Screws |
| 00810111225397 - Guide | 2026-02-02 Targeting Guide |
| 00810111225403 - Guide | 2026-02-02 Targeting Guide |
| 00810111225472 - Drill Guide | 2026-02-02 Drill Guide and Template |
| 00810111225342 - Saw Blade | 2026-01-15 DORSAL AKINATOR™ BLADE - ZMS |
| 00810111226677 - Positioner / Compressor | 2026-01-13 Lightning Block - 3-N-1 adapter |
| 00810111226684 - Positioner / Compressor | 2026-01-13 Lightning Block - Distal Left |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BROACH 75605086 2516123 Live/Registered |
BAE SYSTEMS GLOBAL COMBAT SYSTEMS MUNITIONS LIMITED 1998-12-14 |
![]() BROACH 71645468 0600318 Dead/Cancelled |
DIAMOND SAW WORKS, INC. 1953-04-17 |