Catamaran™ SIJ Fusion System
Sterilization Tray Assembly, JIB Set
3manufacturers in China registered for this device type
42catalogue numbers in this listing
4510(k) clearances naming this product code
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 | Tenon Medical, Inc., United States |
|---|---|
| FDA product code | OUR |
| Device type | Sacroiliac Joint Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K180818 |
| Record published | 2022-12-06 |
| Record revised | 2024-02-19 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 40358 | In distribution | |
| 40295-03 | In distribution | |
| 40336 | In distribution | |
| 40304 | In distribution | |
| 40380 | In distribution | |
| 40350 | In distribution | |
| 40327 | In distribution | |
| 40368 | In distribution | |
| 40330 | In distribution | |
| 40356 | In distribution | |
| 40338 | In distribution | |
| 40360 | In distribution | |
| CS008 | In distribution | |
| 40370 | In distribution | |
| 40302 | In distribution | |
| 40348 | In distribution | |
| 40364 | In distribution | |
| 40316 | In distribution | |
| 40342 | In distribution | |
| 40329 | In distribution | |
| 40366 | In distribution | |
| 40396 | In distribution | |
| 40352 | In distribution | |
| 40322 | In distribution | |
| 40332 | In distribution | |
| 40354 | In distribution | |
| 40362 | In distribution | |
| 40331 | In distribution | |
| 40374 | In distribution | |
| 40334 | In distribution | |
| 40344 | In distribution | |
| 40392 | In distribution | |
| 40295-04 | In distribution | |
| 40340 | In distribution | |
| 40300 | In distribution | |
| 40324 | In distribution | |
| 40346 | In distribution | |
| 40328 | In distribution | |
| 40318 | In distribution | |
| 40320 | In distribution | |
| 40326 | In distribution | |
| 40372 | 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 |
|---|---|
| K260477 | 2026-04-08 |
| K250403 | 2025-03-21 |
| K231944 | 2023-08-24 |
| K180818 | 2018-06-13 |
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.