Silex Sacroiliac Joint Fusion System
SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, PLASMA COATED, 12.5mm DIA X 70mm
3manufacturers in China registered for this device type
57catalogue numbers in this listing
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 | Xtant Medical Holdings, Inc., 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 |
| Record published | 2015-08-31 |
| Record revised | 2022-11-28 (version 5) |
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 15 mm; length 30 to 70 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X079-1270 | Outer Diameter 12.5 mm | In distribution |
| X079-1260-DT | Outer Diameter 12.5 mm | In distribution |
| X079-0765-DT | Outer Diameter 7 mm | In distribution |
| X079-1255PC-DT | Outer Diameter 12.5 mm | In distribution |
| X079-1270PC | Length 70 mm | In distribution |
| X079-0735-DT | Length 35 mm | In distribution |
| X079-0740 | Outer Diameter 7 mm | In distribution |
| X079-1250PC-DT | Length 50 mm | In distribution |
| X079-1250PC | Length 50 mm | In distribution |
| X079-0735 | Length 35 mm | In distribution |
| X079-1230PC | Length 30 mm | In distribution |
| X079-1245PC-DT | Length 45 mm | In distribution |
| X079-1240PC-DT | Length 40 mm | In distribution |
| X079-0745-DT | Length 45 mm | In distribution |
| X079-0802 | Outer Diameter 15 mm | In distribution |
| X079-1270-DT | Outer Diameter 12.5 mm | In distribution |
| X079-1230PC-DT | Length 30 mm | In distribution |
| X079-1265-DT | Outer Diameter 12.5 mm | In distribution |
| X079-0745 | Outer Diameter 7 mm | In distribution |
| X079-1250-DT | Outer Diameter 12.5 mm | In distribution |
| X079-1250 | Length 50 mm | In distribution |
| X079-1245 | Length 45 mm | In distribution |
| X079-1245PC | Length 45 mm | In distribution |
| X079-0730 | Outer Diameter 7 mm | In distribution |
| X079-0800 | Outer Diameter 11 mm | In distribution |
| X079-1265 | Length 65 mm | In distribution |
| X079-1230-DT | Length 30 mm | In distribution |
| X079-1255-DT | Outer Diameter 12.5 mm | In distribution |
| X079-1260PC-DT | Outer Diameter 12.5 mm | In distribution |
| X079-0770 | Outer Diameter 7 mm | In distribution |
| X079-1235PC-DT | Outer Diameter 12.5 mm | In distribution |
| X079-1255PC | Length 55 mm | In distribution |
| X079-1245-DT | Outer Diameter 12.5 mm | In distribution |
| X079-1260PC | Outer Diameter 12.5 mm | In distribution |
| X079-0770-DT | Outer Diameter 7 mm | In distribution |
| X079-1235-DT | Outer Diameter 12.5 mm | In distribution |
| X079-1235 | Length 35 mm | In distribution |
| X079-0755 | Length 55 mm | In distribution |
| X079-1240 | Length 40 mm | In distribution |
| X079-1240PC | Outer Diameter 12.5 mm | In distribution |
| X079-0765 | Outer Diameter 7 mm | In distribution |
| X079-0801 | Outer Diameter 13 mm | In distribution |
| X079-0760 | Length 60 mm | In distribution |
| X079-1235PC | Length 35 mm | In distribution |
| X079-0750-DT | Outer Diameter 7 mm | In distribution |
| X079-0740-DT | Outer Diameter 7 mm | In distribution |
| X079-1240-DT | Outer Diameter 12.5 mm | In distribution |
| X079-1255 | Outer Diameter 12.5 mm | In distribution |
| X079-0730-DT | Outer Diameter 7 mm | In distribution |
| X079-0760-DT | Outer Diameter 7 mm | In distribution |
| X079-0750 | Outer Diameter 7 mm | In distribution |
| X079-1265PC-DT | Outer Diameter 12.5 mm | In distribution |
| X079-1265PC | Outer Diameter 12.5 mm | In distribution |
| X079-1260 | Outer Diameter 12.5 mm | In distribution |
| X079-1230 | Length 30 mm | In distribution |
| X079-1270PC-DT | Length 70 mm | In distribution |
| X079-0755-DT | Outer Diameter 7 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
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.