SI-LOK
SI-LOK is a sacroiliac-joint fusion system using cannulated screws, with optional preassembled contouring washers. The screws may be fully or partly threaded and are available with or…
SI-LOK is a sacroiliac-joint fusion system using cannulated screws, with optional preassembled contouring washers. The screws may be fully or partly threaded and are available with or without slots.
Depending on the approach, one, two or three screws may be placed in a joint. Screws and washers use titanium alloys, and screw configurations include options with or without a hydroxyapatite coating.
Listed Item
T27 Non-Cannulated Shaft, SI-LOK Select Driver, GI1
Placement Instruments
The family includes stainless-steel surgical instruments. Separate reusable ExcelsiusGPS instruments support robotic or freehand navigated procedures, while navigation instruments are intended for use with the Medtronic StealthStation system. These instruments guide preparation and screw placement and are supplied nonsterile.
3manufacturers in China registered for this device type
666catalogue 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 | Globus Medical, Inc., United States |
|---|---|
| FDA product code | OUR |
| Device type | Sacroiliac Joint Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K183119 |
| Record published | 2019-07-13 |
| Record revised | 2025-07-02 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 25 to 110 mm; outer diameter 8 to 12 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1202.7270S | Length 70 mm | In distribution |
| 139.682S | Outer Diameter 8 mm | In distribution |
| 139.703S | Outer Diameter 10 mm | In distribution |
| 139.294 | Outer Diameter 9 mm | In distribution |
| 1202.4235 | Length 35 mm | In distribution |
| 1202.6270 | Length 70 mm | In distribution |
| 1202.6260S | Outer Diameter 12 mm | In distribution |
| 1202.6005 | Outer Diameter 10 mm | In distribution |
| 1202.7295 | Outer Diameter 12 mm | In distribution |
| 1202.6235 | Outer Diameter 12 mm | In distribution |
| 1202.1010S | Length 110 mm | In distribution |
| 1202.1075S | Outer Diameter 10 mm | In distribution |
| 1202.4065S | Outer Diameter 10 mm | In distribution |
| 1202.7025S | Outer Diameter 10 mm | In distribution |
| 1202.8250S | Length 50 mm | In distribution |
| 1202.1230S | Length 30 mm | In distribution |
| 1202.5085S | Length 85 mm | In distribution |
| 1202.2095S | Length 95 mm | In distribution |
| 1202.7230 | Length 30 mm | In distribution |
| 1202.6295 | Length 95 mm | In distribution |
| 1202.3240S | Outer Diameter 12 mm | In distribution |
| 1202.6035S | Outer Diameter 10 mm | In distribution |
| 1202.3255 | Outer Diameter 12 mm | In distribution |
| 1202.4040 | Length 40 mm | In distribution |
| 1202.7280 | Length 80 mm | In distribution |
| 1202.6225S | Length 25 mm | In distribution |
| 1202.3010S | Length 110 mm | In distribution |
| 1202.2285 | Outer Diameter 12 mm | In distribution |
| 1202.8285 | Length 85 mm | In distribution |
| 1202.2090S | Outer Diameter 10 mm | In distribution |
| 1202.3090 | Outer Diameter 10 mm | In distribution |
| 1202.5035 | Length 35 mm | In distribution |
| 1202.8295 | Length 95 mm | In distribution |
| 1202.2280S | Outer Diameter 12 mm | In distribution |
| 1202.5260 | Outer Diameter 12 mm | In distribution |
| 1202.2095 | Length 95 mm | In distribution |
| 1202.4290 | Outer Diameter 12 mm | In distribution |
| 139.714S | Outer Diameter 11 mm | In distribution |
| 1202.2080S | Length 80 mm | In distribution |
| 1202.1035S | Length 35 mm | In distribution |
| 1202.8275S | Length 75 mm | In distribution |
| 1202.8270S | Outer Diameter 12 mm | In distribution |
| 1202.7250S | Length 50 mm | In distribution |
| 1202.6040 | Outer Diameter 10 mm | In distribution |
| 1202.2250S | Length 50 mm | In distribution |
| 1202.8040S | Outer Diameter 10 mm | In distribution |
| 1202.3240 | Length 40 mm | In distribution |
| 1202.1285 | Outer Diameter 12 mm | In distribution |
| 1202.2000 | Outer Diameter 10 mm | In distribution |
| 1202.7030 | Length 30 mm | In distribution |
| 1202.4000S | Outer Diameter 10 mm | In distribution |
| 1202.4025S | Length 25 mm | In distribution |
| 1202.7055 | Length 55 mm | In distribution |
| 139.106 | Outer Diameter 10 mm | In distribution |
| 139.306 | Outer Diameter 10 mm | In distribution |
| 1202.2005 | Outer Diameter 10 mm | In distribution |
| 1202.1250 | Length 50 mm | In distribution |
| 1202.1095S | Length 95 mm | In distribution |
| 1202.2270 | Outer Diameter 12 mm | In distribution |
| 1202.5065 | Length 65 mm | In distribution |
| 1202.4295S | Length 95 mm | In distribution |
| 1202.7090S | Outer Diameter 10 mm | In distribution |
| 139.712S | Outer Diameter 11 mm | In distribution |
| 1202.2055 | Length 55 mm | In distribution |
| 1202.8010 | Outer Diameter 10 mm | In distribution |
| 1202.5030 | Outer Diameter 10 mm | In distribution |
| 1202.4260S | Length 60 mm | In distribution |
| 1202.1060S | Length 60 mm | In distribution |
| 1202.7010 | Length 110 mm | In distribution |
| 1202.1210 | Outer Diameter 12 mm | In distribution |
| 1202.3040S | Outer Diameter 10 mm | In distribution |
| 1202.5235S | Outer Diameter 12 mm | In distribution |
| 1202.6010S | Length 110 mm | In distribution |
| 1202.2200S | Outer Diameter 12 mm | In distribution |
| 1202.8095S | Outer Diameter 10 mm | In distribution |
| 1202.1050S | Length 50 mm | In distribution |
| 139.814S | Outer Diameter 11 mm | In distribution |
| 1202.1085 | Outer Diameter 10 mm | In distribution |
| 1202.2045 | Length 45 mm | In distribution |
| 139.826S | Length 50 mm | In distribution |
| 1202.2060 | Length 60 mm | In distribution |
| 1202.7050S | Length 50 mm | In distribution |
| 1202.4095S | Length 95 mm | In distribution |
| 1202.5080 | Length 80 mm | In distribution |
| 1202.5050S | Outer Diameter 10 mm | In distribution |
| 1202.8230S | Length 30 mm | In distribution |
| 139.684S | Outer Diameter 8 mm | In distribution |
| 1202.6095 | Outer Diameter 10 mm | In distribution |
| 1202.1265S | Outer Diameter 12 mm | In distribution |
| 1202.5010S | Outer Diameter 10 mm | In distribution |
| 1202.6045 | Length 45 mm | In distribution |
| 1202.1240S | Length 40 mm | In distribution |
| 139.707S | Outer Diameter 10 mm | In distribution |
| 139.784S | Length 40 mm | In distribution |
| 139.605S | Length 45 mm | In distribution |
| 1202.4060 | Outer Diameter 10 mm | In distribution |
| 1202.6200 | Length 100 mm | In distribution |
| 1202.4090 | Outer Diameter 10 mm | In distribution |
| 1202.4060S | Length 60 mm | In distribution |
| 139.297 | Length 55 mm | In distribution |
| 1202.6055S | Outer Diameter 10 mm | In distribution |
| 1202.6095S | Length 95 mm | In distribution |
| 139.292 | Length 30 mm | In distribution |
| 139.518S | Length 60 mm | In distribution |
| 1202.2255 | Length 55 mm | In distribution |
| 1202.4230 | Length 30 mm | In distribution |
| 1202.7080 | Outer Diameter 10 mm | In distribution |
| 1202.4205 | Length 105 mm | In distribution |
| 1202.8005S | Length 105 mm | In distribution |
| 1202.2260S | Length 60 mm | In distribution |
| 1202.2290 | Outer Diameter 12 mm | In distribution |
| 1202.2030S | Outer Diameter 10 mm | In distribution |
| 1202.5290S | Outer Diameter 12 mm | In distribution |
| 1202.8080S | Length 80 mm | In distribution |
| 1202.1030 | Length 30 mm | In distribution |
| 1202.2085S | Length 85 mm | In distribution |
| 1202.2245S | Outer Diameter 12 mm | In distribution |
| 1202.5090 | Outer Diameter 10 mm | In distribution |
| 1202.1005S | Outer Diameter 10 mm | In distribution |
| 1202.1290S | Length 90 mm | In distribution |
| 1202.7255 | Outer Diameter 12 mm | In distribution |
| 1202.7000S | Outer Diameter 10 mm | In distribution |
| 1202.1270S | Length 70 mm | In distribution |
| 1202.2035S | Outer Diameter 10 mm | In distribution |
| 1202.8030S | Length 30 mm | In distribution |
| 1202.4085 | Outer Diameter 10 mm | In distribution |
| 1202.6000S | Outer Diameter 10 mm | In distribution |
| 1202.5060S | Outer Diameter 10 mm | In distribution |
| 1202.6005S | Length 105 mm | In distribution |
| 1202.8060 | Length 60 mm | In distribution |
| 1202.3285 | Length 85 mm | In distribution |
| 1202.2005S | Length 105 mm | In distribution |
| 1202.5275 | Length 75 mm | In distribution |
| 1202.6085 | Outer Diameter 10 mm | In distribution |
| 1202.8275 | Length 75 mm | In distribution |
| 1202.1230 | Outer Diameter 12 mm | In distribution |
| 1202.4275 | Length 75 mm | In distribution |
| 1202.8025S | Length 25 mm | In distribution |
| 1202.7225 | Outer Diameter 12 mm | In distribution |
| 1202.4005 | Length 105 mm | In distribution |
| 1202.4250 | Length 50 mm | In distribution |
| 139.316 | Length 50 mm | In distribution |
| 1202.8000S | Outer Diameter 10 mm | In distribution |
| 1202.1075 | Outer Diameter 10 mm | In distribution |
| 1202.8290 | Outer Diameter 12 mm | In distribution |
| 1202.4095 | Length 95 mm | In distribution |
| 1202.7265S | Outer Diameter 12 mm | In distribution |
| 1202.8055 | Length 55 mm | In distribution |
| 1202.3040 | Length 40 mm | In distribution |
| 1202.1080 | Outer Diameter 10 mm | In distribution |
| 1202.3005 | Outer Diameter 10 mm | In distribution |
| 1202.7075S | Outer Diameter 10 mm | In distribution |
| 1202.8270 | Length 70 mm | In distribution |
| 1202.8265 | Outer Diameter 12 mm | In distribution |
| 1202.2205 | Length 105 mm | In distribution |
| 1202.2085 | Outer Diameter 10 mm | In distribution |
| 1202.8260 | Length 60 mm | In distribution |
| 1202.3010 | Length 110 mm | In distribution |
| 1202.5205 | Outer Diameter 12 mm | In distribution |
| 1202.8240S | Length 40 mm | In distribution |
| 1202.5055 | Length 55 mm | In distribution |
| 1202.3210 | Length 110 mm | In distribution |
| 1202.3230 | Outer Diameter 12 mm | In distribution |
| 1202.6050 | Outer Diameter 10 mm | In distribution |
| 1202.1040S | Outer Diameter 10 mm | In distribution |
| 1202.4265 | Outer Diameter 12 mm | In distribution |
| 1202.2210S | Length 110 mm | In distribution |
| 1202.4245S | Length 45 mm | In distribution |
| 1202.3095 | Length 95 mm | In distribution |
| 1202.5085 | Outer Diameter 10 mm | In distribution |
| 6202.6651 | In distribution | |
| 1202.3295 | Length 95 mm | In distribution |
| 139.617S | Outer Diameter 11 mm | In distribution |
| 1202.6285S | Length 85 mm | In distribution |
| 1202.5230 | Outer Diameter 12 mm | In distribution |
| 1202.3075S | Length 75 mm | In distribution |
| 1202.5285 | Length 85 mm | In distribution |
| 1202.3070 | Outer Diameter 10 mm | In distribution |
| 1202.7040 | Length 40 mm | In distribution |
| 1202.3065 | Length 65 mm | In distribution |
| 1202.7275 | Outer Diameter 12 mm | In distribution |
| 139.286 | Length 50 mm | In distribution |
| 139.717S | Outer Diameter 11 mm | In distribution |
| 1202.6090 | Outer Diameter 10 mm | In distribution |
| 1202.5285S | Outer Diameter 12 mm | In distribution |
| 1202.3225 | Length 25 mm | In distribution |
| 1202.3290 | Outer Diameter 12 mm | In distribution |
| 1202.3245 | Outer Diameter 12 mm | In distribution |
| 1202.3230S | Outer Diameter 12 mm | In distribution |
| 1202.8280S | Length 80 mm | In distribution |
| 1202.8080 | Outer Diameter 10 mm | In distribution |
| 1202.6260 | Outer Diameter 12 mm | In distribution |
| 1202.1065S | Outer Diameter 10 mm | In distribution |
| 1202.5050 | Length 50 mm | In distribution |
| 1202.6205 | Length 105 mm | In distribution |
| 1202.1000S | Length 100 mm | In distribution |
| 1202.6205S | Outer Diameter 12 mm | In distribution |
| 1202.2075 | Length 75 mm | In distribution |
| 1202.5010 | Length 110 mm | In distribution |
| 1202.2285S | Outer Diameter 12 mm | In distribution |
| 1202.5235 | Outer Diameter 12 mm | In distribution |
| 139.723S | Outer Diameter 12 mm | In distribution |
| 1202.5265 | Outer Diameter 12 mm | In distribution |
| 1202.2075S | Outer Diameter 10 mm | In distribution |
| 1202.5280 | Outer Diameter 12 mm | In distribution |
| 1202.6210S | Outer Diameter 12 mm | In distribution |
| 1202.6090S | Outer Diameter 10 mm | In distribution |
| 139.417 | Length 55 mm | In distribution |
| 1202.3245S | Outer Diameter 12 mm | In distribution |
| 139.798S | Length 60 mm | In distribution |
| 1202.7285S | Length 85 mm | In distribution |
| 1202.3205S | Length 105 mm | In distribution |
| 1202.6275 | Outer Diameter 12 mm | In distribution |
| 1202.7235 | Length 35 mm | In distribution |
| 1202.7230S | Length 30 mm | In distribution |
| 1202.3005S | Length 105 mm | In distribution |
| 1202.2295 | Outer Diameter 12 mm | In distribution |
| 1202.8085 | Outer Diameter 10 mm | In distribution |
| 1202.5025 | Length 25 mm | In distribution |
| 1202.4035S | Length 35 mm | In distribution |
| 139.525S | Length 45 mm | In distribution |
| 1202.1245S | Outer Diameter 12 mm | In distribution |
| 1202.5255S | Length 55 mm | In distribution |
| 139.787S | Outer Diameter 8 mm | In distribution |
| 1202.6025 | Outer Diameter 10 mm | In distribution |
| 1202.4055 | Outer Diameter 10 mm | In distribution |
| 1202.5265S | Outer Diameter 12 mm | In distribution |
| 1202.8025 | Outer Diameter 10 mm | In distribution |
| 1202.7255S | Outer Diameter 12 mm | In distribution |
| 1202.2265 | Length 65 mm | In distribution |
| 1202.5025S | Length 25 mm | In distribution |
| 1202.7210S | Outer Diameter 12 mm | In distribution |
| 1202.3030S | Length 30 mm | In distribution |
| 1202.5210S | Outer Diameter 12 mm | In distribution |
| 1202.8235S | Outer Diameter 12 mm | In distribution |
| 1202.6000 | Outer Diameter 10 mm | In distribution |
| 1202.5075 | Outer Diameter 10 mm | In distribution |
| 139.694S | Length 40 mm | In distribution |
| 1202.5255 | Outer Diameter 12 mm | In distribution |
| 1202.7280S | Length 80 mm | In distribution |
| 139.308 | Outer Diameter 10 mm | In distribution |
| 1202.8245 | Outer Diameter 12 mm | In distribution |
| 139.505S | Length 45 mm | In distribution |
| 1202.5005 | Length 105 mm | In distribution |
| 139.696S | Length 50 mm | In distribution |
| 1202.2240S | Outer Diameter 12 mm | In distribution |
| 1202.5035S | Length 35 mm | In distribution |
| 1202.8205 | Length 105 mm | In distribution |
| 1202.3250 | Length 50 mm | In distribution |
| 1202.8060S | Outer Diameter 10 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Dynamis™ Implant System | Promethean Restorative Inc. | 120 |
Showing 12 of 534. All products under Sacroiliac Joint Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K183119 | 2019-02-06 |
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.