Samba Screw System
40mm SAMBA Screw; The SAMBA™ Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.
3manufacturers in China registered for this device type
22catalogue 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 | Medical Designs, LLC, United States |
|---|---|
| FDA product code | OUR |
| Device type | Sacroiliac Joint Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| 510(k) | K121148 |
| Record published | 2016-09-27 |
| Record revised | 2022-11-28 (version 5) |
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 |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 9 mm; length 35 to 50 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 11-1109-FD21 | 10 | In distribution | |
| 11-1109-FD17 | In distribution | ||
| 11-1109-FD7-1 | In distribution | ||
| 11-1109-FD9-2 | In distribution | ||
| 11-1109-FD19 | In distribution | ||
| 11-1109-FD4 | Outer Diameter 9 mm | In distribution | |
| 11-1109-FD3 | Outer Diameter 9 mm | In distribution | |
| 11-1109-FD8-2 | In distribution | ||
| 11-1109-FD10 | In distribution | ||
| 11-1109-FD14 | In distribution | ||
| 11-1109-FD16 | 24 | In distribution | |
| 11-1109-FD6 | Outer Diameter 9 mm | In distribution | |
| 11-1109-FD9-1 | In distribution | ||
| 11-1109-FD13 | In distribution | ||
| 11-1109-FD5 | Outer Diameter 9 mm | In distribution | |
| 11-1109-FD18 | In distribution | ||
| 11-1109-FD7-3 | In distribution | ||
| 11-1109-FD7-2 | In distribution | ||
| 11-1109-FD11 | In distribution | ||
| 11-1109-FD15 | In distribution | ||
| 11-1109-FD8-1 | In distribution | ||
| 11-1109-FD20 | 5 | 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.