SiJoin T4 Titanium
SiJoin T4 Titanium 16x30x5 Implant
3manufacturers in China registered for this device type
13catalogue 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 | VGI medical, LLC, United States |
|---|---|
| FDA product code | OUR |
| Device type | Sacroiliac Joint Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K213815 |
| Record published | 2023-12-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Sizes | Width 16 to 22 mm; length 20 to 50 mm; height 5 to 7.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VG-SJ-T4-21630 | Width 16 mm | In distribution |
| VG-SJ-T4-21650 | Width 16 mm | In distribution |
| VG-SJ-T4-21635 | Width 16 mm | In distribution |
| VG-SJ-T4-22220 | Width 22 mm | In distribution |
| VG-SJ-T4-22250 | Width 22 mm | In distribution |
| VG-SJ-T4-22240 | Width 22 mm | In distribution |
| VG-SJ-T4-22235 | Width 22 mm | In distribution |
| VG-SJ-T4-2224075 | Width 22 mm | In distribution |
| VG-SJ-T4-21640 | Width 16 mm | In distribution |
| VG-SJ-T4-21620 | Width 16 mm | In distribution |
| VG-SJ-T4-22225 | Width 22 mm | In distribution |
| VG-SJ-T4-22230 | Width 22 mm | In distribution |
| VG-SJ-T4-21625 | Width 16 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 |
|---|---|
| K213815 | 2023-03-29 |
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.