| Primary Device ID | 00810111222778 |
| NIH Device Record Key | d487abe0-98ae-4a6f-af9d-09487c54093e |
| Commercial Distribution Discontinuation | 2024-04-19 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Cut Guide |
| Version Model Number | 02-00197 |
| 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 | 00810111222778 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810111222778]
Moist Heat or Steam Sterilization
[00810111222778]
Moist Heat or Steam Sterilization
[00810111222778]
Moist Heat or Steam Sterilization
[00810111222778]
Moist Heat or Steam Sterilization
[00810111222778]
Moist Heat or Steam Sterilization
[00810111222778]
Moist Heat or Steam Sterilization
[00810111222778]
Moist Heat or Steam Sterilization
[00810111222778]
Moist Heat or Steam Sterilization
[00810111222778]
Moist Heat or Steam Sterilization
[00810111222778]
Moist Heat or Steam Sterilization
[00810111222778]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-29 |
| Device Publish Date | 2024-04-19 |
| 00853114006990 | lesser TMT cut guide |
| 00853114006976 | lesser TMT cut guide |
| 00853114006846 | Cut Guide - platinum |
| 00853114006839 | MIS cut guide - gold |
| 00853114006822 | cut guide low angle (short) |
| 00853114006815 | cut guide low angle - gold |
| 00853114006761 | cut guide |
| 00853114006563 | rotational cut guide |
| 00853114006549 | cut guide |
| 00853114006532 | cut guide |
| 00810111221368 | lesser TMT cut guide |
| 00810111221351 | lesser TMT cut guide |
| 00810111221122 | Cut Guide |
| 00810111221115 | Cut Guide |
| 00810111221108 | Cut Guide |
| 00810111220484 | Low pro cut guide |
| 00810111220477 | low pro cut guide |
| 00810111220460 | low pro cut guide |
| 00810111220453 | low pro cut guide |
| 00810111220446 | low pro cut guide |
| 00810111220439 | low pro cut guide |
| 00810111220422 | low pro cut guide |
| 00810111220415 | cut guide - double |
| 00810111220361 | cut guide |
| 00810111220347 | lesser TMT cut guide medium |
| 00810111220330 | lesser TMT cut guide large |
| 00810111220323 | lesser TMT cut guide medium |
| 00810111220316 | lesser TMT cut guide small |
| 00810111220255 | cut guide |
| 00810111220583 | Cut Guide |
| 00810111222068 | MTA Stepped Cut Guide |
| 00810111222051 | MTA Stepped Cut Guide |
| 00810111222815 | STEPPED INLINE CUT GUIDE, LARGE |
| 00810111222808 | STEPPED INLINE CUT GUIDE, MEDIUM |
| 00810111222792 | STEPPED INLINE CUT GUIDE, SMALL |
| 00810111222778 | Cut Guide |
| 00810111222662 | Single Slot Cut Guide |
| 00810111223676 | Single Slot Cut Guide |
| 00810111223935 | Cut Guide |