SI-Lution Sacroiliac Joint Fusion System
Sacroiliac Screw, Fully Threaded, 9.5 x 50mm
3manufacturers in China registered for this device type
60catalogue numbers in this listing
1510(k) clearance
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 | Curiteva, Inc., United States |
|---|---|
| FDA product code | OUR |
| Device type | Sacroiliac Joint Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K210402 |
| Record published | 2021-09-17 |
| Record revised | 2023-12-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Outer diameter 7 to 12 mm; length 30 to 70 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C614-9550 | Outer Diameter 9.5 mm | In distribution |
| C614-1255-H | Outer Diameter 12 mm | In distribution |
| C614-7065-H | Outer Diameter 7 mm | In distribution |
| C614-7055 | Length 55 mm | In distribution |
| C614-1245-H | Outer Diameter 12 mm | In distribution |
| C614-9545-H | Outer Diameter 9.5 mm | In distribution |
| C614-7040-H | Outer Diameter 7 mm | In distribution |
| C614-1260-H | Outer Diameter 12 mm | In distribution |
| C614-9555 | Outer Diameter 9.5 mm | In distribution |
| C614-7045 | Length 45 mm | In distribution |
| C614-70-KC | 7mm | In distribution |
| C614-7035-H | Outer Diameter 7 mm | In distribution |
| C614-7070-H | Outer Diameter 7 mm | In distribution |
| C614-9535-H | Outer Diameter 9.5 mm | In distribution |
| C614-12-KC | 12mm | In distribution |
| C614-9565-H | Outer Diameter 9.5 mm | In distribution |
| C614-9545 | Outer Diameter 9.5 mm | In distribution |
| C614-1265 | Outer Diameter 12 mm | In distribution |
| C614-1235 | Outer Diameter 12 mm | In distribution |
| C614-1260 | Outer Diameter 12 mm | In distribution |
| C614-9560 | Outer Diameter 9.5 mm | In distribution |
| C614-1250-H | Outer Diameter 12 mm | In distribution |
| C614-7050-H | Outer Diameter 7 mm | In distribution |
| C614-7030-H | Outer Diameter 7 mm | In distribution |
| C614-70-SC | 7mm | In distribution |
| C614-1270-H | Outer Diameter 12 mm | In distribution |
| C614-7040 | Outer Diameter 7 mm | In distribution |
| C614-1250 | Outer Diameter 12 mm | In distribution |
| C614-1235-H | Outer Diameter 12 mm | In distribution |
| C614-9540 | Outer Diameter 9.5 mm | In distribution |
| C614-7045-H | Outer Diameter 7 mm | In distribution |
| C614-7070 | Outer Diameter 7 mm | In distribution |
| C614-12-SC | 12mm | In distribution |
| C614-95-KC | 9.5mm | In distribution |
| C614-9540-H | Outer Diameter 9.5 mm | In distribution |
| C614-95-SC | 9.5mm | In distribution |
| C614-9535 | Outer Diameter 9.5 mm | In distribution |
| C614-7035 | Length 35 mm | In distribution |
| C614-1230 | Outer Diameter 12 mm | In distribution |
| C614-1230-H | Outer Diameter 12 mm | In distribution |
| C614-1240-H | Outer Diameter 12 mm | In distribution |
| C614-1245 | Outer Diameter 12 mm | In distribution |
| C614-9530-H | Outer Diameter 9.5 mm | In distribution |
| C614-7060 | Outer Diameter 7 mm | In distribution |
| C614-9560-H | Outer Diameter 9.5 mm | In distribution |
| C614-9550-H | Outer Diameter 9.5 mm | In distribution |
| C614-9565 | Outer Diameter 9.5 mm | In distribution |
| C614-1255 | Outer Diameter 12 mm | In distribution |
| C614-1270 | Outer Diameter 12 mm | In distribution |
| C614-7030 | Outer Diameter 7 mm | In distribution |
| C614-9555-H | Outer Diameter 9.5 mm | In distribution |
| C614-9570 | Outer Diameter 9.5 mm | In distribution |
| C614-7050 | Outer Diameter 7 mm | In distribution |
| C614-1240 | Outer Diameter 12 mm | In distribution |
| C614-9570-H | Outer Diameter 9.5 mm | In distribution |
| C614-7065 | Length 65 mm | In distribution |
| C614-7055-H | Outer Diameter 7 mm | In distribution |
| C614-7060-H | Outer Diameter 7 mm | In distribution |
| C614-9530 | Outer Diameter 9.5 mm | In distribution |
| C614-1265-H | Outer Diameter 12 mm | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210402 | 2021-09-09 |
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.