| Primary Device ID | 00810021866451 |
| NIH Device Record Key | 71eb23f1-1b53-4e3c-95c5-b9035b08ed5e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoLink Mfx |
| Version Model Number | C02 N0031 |
| Catalog Number | C02 N0031 |
| Company DUNS | 079700711 |
| Company Name | IN2BONES USA, LLC |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 00810021866451 [Primary] |
| FZX | Guide, surgical, instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810021866451]
Moist Heat or Steam Sterilization
[00810021866451]
Moist Heat or Steam Sterilization
[00810021866451]
Moist Heat or Steam Sterilization
[00810021866451]
Moist Heat or Steam Sterilization
[00810021866451]
Moist Heat or Steam Sterilization
[00810021866451]
Moist Heat or Steam Sterilization
[00810021866451]
Moist Heat or Steam Sterilization
[00810021866451]
Moist Heat or Steam Sterilization
[00810021866451]
Moist Heat or Steam Sterilization
[00810021866451]
Moist Heat or Steam Sterilization
[00810021866451]
Moist Heat or Steam Sterilization
[00810021866451]
Moist Heat or Steam Sterilization
[00810021866451]
Moist Heat or Steam Sterilization
[00810021866451]
Moist Heat or Steam Sterilization
[00810021866451]
Moist Heat or Steam Sterilization
[00810021866451]
Moist Heat or Steam Sterilization
[00810021866451]
Moist Heat or Steam Sterilization
[00810021866451]
Moist Heat or Steam Sterilization
[00810021866451]
Moist Heat or Steam Sterilization
[00810021866451]
Moist Heat or Steam Sterilization
[00810021866451]
Moist Heat or Steam Sterilization
[00810021866451]
Moist Heat or Steam Sterilization
[00810021866451]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-12-31 |
| Device Publish Date | 2024-12-10 |
| 00810021866512 | LISFRANC TARGETING GUIDE, ASSEMBLY |
| 00810021866499 | LISFRANC TARGETING GUIDE, RATCHET TUBE, SUB-ASSEMBLY |
| 00810021866482 | LISFRANC TARGETING GUIDE, GUIDE CLAMP, SUB-ASSEMBLY |
| 00810021866475 | LISFRANC SCREW DEPTH GAUGE |
| 00810021866468 | LISFRANC K-WIRE GUIDE, Ø1.6 MM |
| 00810021866451 | LISFRANC TARGETING GUIDE, ROD |
| 00810021866444 | LISFRANC DRIVER, T15, CANNULATED, NON-STERILE |
| 00810021866437 | LISFRANC DRILL, Ø2.7 MM, CANNULATED, NON-STERILE |
| 00810021866420 | LisFranc Driver, T15, Cannulated, Sterile, Single-Use |
| 00810021866413 | Lisfranc Drill, Ø2.7 mm, Cannulated, Sterile, Single-Use |
| 00810021864815 | MEDIAL COLUMN NCM PLATE TRIAL, STANDARD |
| 00810021864808 | MEDIAL COLUMN TNC PLATE TRIAL, STANDARD |
| 00810021864792 | MEDIAL COLUMN BRIDGE PLATE TRIAL, STANDARD |
| 00810021864785 | TN PLATE TRIAL, STANDARD |
| 00810021864778 | NC PLATE TRIAL, STANDARD |
| 00810021864761 | 2ND/3RD LISFRANC PLATE TRIAL, LARGE |
| 00810021864754 | 2ND/3RD LISFRANC PLATE TRIAL, SMALL |
| 00810021864747 | 1ST/2ND LISFRANC PLATE TRIAL, SMALL, RIGHT |
| 00810021864730 | 1ST/2ND LISFRANC PLATE TRIAL, SMALL, LEFT |
| 00810021864723 | 1ST/2ND LISFRANC PLATE TRIAL, LARGE, RIGHT |
| 00810021864709 | 1ST TMT LISFRANC PLATE TRIAL |
| 00810021864693 | CoLink Mfx, TRANSVERSE WIRE GUIDE, Ø4.0 CoLag SCREW |