Firebird SI Fusion
11MM X 50MM Firebird SI Screw, Firebird SI Fusion System, Sterile
3manufacturers in China registered for this device type
40catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Guangdong (1), Shandong (1), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Autocam Medical Devices (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
Record
| Listed by | Orthofix US LLC, United States |
|---|---|
| FDA product code | OUR |
| Device type | Sacroiliac Joint Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K183342 |
| Record published | 2025-04-02 |
| Record revised | 2026-02-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 18-1050SP | In distribution | |
| 18-1045SP | In distribution | |
| 18-0970 | In distribution | |
| 18-0960 | In distribution | |
| 18-2035SP | In distribution | |
| 18-0930 | In distribution | |
| 18-0955 | In distribution | |
| 18-0925 | In distribution | |
| 18-1065SP | In distribution | |
| 18-2070SP | In distribution | |
| 18-0965 | In distribution | |
| 18-0945SP | In distribution | |
| 18-0925SP | In distribution | |
| 18-0960SP | In distribution | |
| 18-0965SP | In distribution | |
| 18-0930SP | In distribution | |
| 18-0950SP | In distribution | |
| 18-1040SP | In distribution | |
| 18-1030SP | In distribution | |
| 18-0955SP | In distribution | |
| 18-0940SP | In distribution | |
| 18-2060SP | In distribution | |
| 18-2030SP | In distribution | |
| 18-2045SP | In distribution | |
| 18-2025SP | In distribution | |
| 18-1055SP | In distribution | |
| 18-0950 | In distribution | |
| 18-2055SP | In distribution | |
| 18-2040SP | In distribution | |
| 18-0935SP | In distribution | |
| 18-2065SP | In distribution | |
| 18-2050SP | In distribution | |
| 18-1035SP | In distribution | |
| 18-0945 | In distribution | |
| 18-1025SP | In distribution | |
| 18-1070SP | In distribution | |
| 18-0935 | In distribution | |
| 18-1060SP | In distribution | |
| 18-0970SP | In distribution | |
| 18-0940 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SI-LOK | Globus Medical, Inc. | 666 |
| Sacroiliac Joint Fusion System | Genesys Orthopedics Systems, LLC | 356 |
| SIros-X | Genesys Orthopedics Systems, LLC | 353 |
| PathLoc- SI Joint Fusion System | L&K Biomed Co., Ltd. | 229 |
| ARx SAI | Life Spine | 224 |
| Unity | Diomedical Co., Ltd. | 198 |
| SImmetry SI Joint Fusion System | Tenon Medical, Inc. | 173 |
| M.u.s.t. Sacral Iliac Screw and Pelvic Trauma System | Medacta International SA | 170 |
| Integrity-SI Fusion System | Lincotek Medical, LLC | 160 |
| Zespin SI Joint Fusion System | Aegis Spine | 150 |
| M.u.s.t. Sacral Iliac Screw System | Medacta International SA | 142 |
| Simmetry | Sivantage | 123 |
Showing 12 of 534. All products under Sacroiliac Joint Fixation
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Orthofix US LLC | UDI-DI | 2025-11-03 | Class III | Device Design | Labeling contains claims that are not consistently present. | 19431 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.