| Primary Device ID | 18257200165124 |
| NIH Device Record Key | ecfe2455-15b8-4193-a16a-f043fbd5f50e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Firebird SI Navigation System |
| Version Model Number | 18-1905 |
| Company DUNS | 927083808 |
| Company Name | Orthofix US LLC |
| 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 |
| Phone | +1(214)937-3199 |
| osi-customerservice@orthofix.com | |
| Phone | +1(214)937-3199 |
| osi-customerservice@orthofix.com | |
| Phone | +1(214)937-3199 |
| osi-customerservice@orthofix.com | |
| Phone | +1(214)937-3199 |
| osi-customerservice@orthofix.com | |
| Phone | +1(214)937-3199 |
| osi-customerservice@orthofix.com | |
| Phone | +1(214)937-3199 |
| osi-customerservice@orthofix.com | |
| Phone | +1(214)937-3199 |
| osi-customerservice@orthofix.com | |
| Phone | +1(214)937-3199 |
| osi-customerservice@orthofix.com | |
| Phone | +1(214)937-3199 |
| osi-customerservice@orthofix.com | |
| Phone | +1(214)937-3199 |
| osi-customerservice@orthofix.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18257200165124 [Primary] |
| FZX | Guide, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18257200165124]
Moist Heat or Steam Sterilization
[18257200165124]
Moist Heat or Steam Sterilization
[18257200165124]
Moist Heat or Steam Sterilization
[18257200165124]
Moist Heat or Steam Sterilization
[18257200165124]
Moist Heat or Steam Sterilization
[18257200165124]
Moist Heat or Steam Sterilization
[18257200165124]
Moist Heat or Steam Sterilization
[18257200165124]
Moist Heat or Steam Sterilization
[18257200165124]
Moist Heat or Steam Sterilization
[18257200165124]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-11-28 |
| Device Publish Date | 2025-11-20 |
| 18257200165148 | FIREBIRD SI NAV TRAJECTORY GUIDE |
| 18257200165131 | PIN SLEEVE |
| 18257200165124 | DRILL GUIDE |
| 18257200165223 | FIREBIRD SI NAVIGATED INTRUMENT CASE |
| 18257200165193 | MDT INLINE ADAPTER |
| 18257200164950 | 12mm DRILL, NAVIGATED |
| 18257200164943 | 11mm DRILL, NAVIGATED |
| 18257200164936 | 9mm DRILL, NAVIGATED |
| 18257200164929 | SCREW DRIVER, NAVIGATED |