| Primary Device ID | 00810112597875 |
| NIH Device Record Key | 48ed169f-f109-4be9-8724-d60e76a6b97a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MiniBunion |
| Version Model Number | MiniBunion Saw Guide |
| Catalog Number | 280041PKG |
| Company DUNS | 058864308 |
| Company Name | CROSSROADS EXTREMITY SYSTEMS |
| 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 | 00810112597875 [Primary] |
| FZX | Guide, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810112597875]
Moist Heat or Steam Sterilization
[00810112597875]
Moist Heat or Steam Sterilization
[00810112597875]
Moist Heat or Steam Sterilization
[00810112597875]
Moist Heat or Steam Sterilization
[00810112597875]
Moist Heat or Steam Sterilization
[00810112597875]
Moist Heat or Steam Sterilization
[00810112597875]
Moist Heat or Steam Sterilization
[00810112597875]
Moist Heat or Steam Sterilization
[00810112597875]
Moist Heat or Steam Sterilization
[00810112597875]
Moist Heat or Steam Sterilization
[00810112597875]
Moist Heat or Steam Sterilization
[00810112597875]
Moist Heat or Steam Sterilization
[00810112597875]
Moist Heat or Steam Sterilization
[00810112597875]
Moist Heat or Steam Sterilization
[00810112597875]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-15 |
| Device Publish Date | 2024-08-07 |
| 00815432029228 | The MiniBunion Plating System is intended for fixation of osteotomies and corrective procedures |
| 00810112597875 | MiniBunion Saw Guide |
| 00810112597868 | MIS Bunion Plate Inserter |
| 00810112597851 | MiniBunion Instruments Tray |
| 00810112597844 | MiniBunion Non-Locking Drill Guide |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MINIBUNION 88244621 not registered Live/Pending |
Crossroads Extremity Systems 2018-12-28 |