Cassatt
D6.5 x L70,Cannulated,T25 Hexalobular, Lag-Screw
3manufacturers in China registered for this device type
30catalogue 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 | CTL Medical Corporation, 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 |
| 510(k) | K211785 |
| Record published | 2025-06-02 |
| Record revised | 2025-12-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2025-12-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 133.7367 | Withdrawn | |
| 133.7307 | Withdrawn | |
| 133.7366 | Withdrawn | |
| 133.7376 | Withdrawn | |
| 133.0670 | Withdrawn | |
| 133.7457 | Withdrawn | |
| 133.7458 | Withdrawn | |
| 133.7030 | Withdrawn | |
| 133.7368 | Withdrawn | |
| 133.0001 | Withdrawn | |
| 133.7292 | Withdrawn | |
| 133.7308 | Withdrawn | |
| 133.0002 | Withdrawn | |
| 133.7456 | Withdrawn | |
| 133.7348 | Withdrawn | |
| 133.7378 | Withdrawn | |
| 133.0680 | Withdrawn | |
| 133.7406 | Withdrawn | |
| 133.7408 | Withdrawn | |
| 133.7416 | Withdrawn | |
| 133.7417 | Withdrawn | |
| 133.7346 | Withdrawn | |
| 133.7540 | Withdrawn | |
| 133.7347 | Withdrawn | |
| 133.7377 | Withdrawn | |
| 133.7418 | Withdrawn | |
| 133.7306 | Withdrawn | |
| 133.0003 | Withdrawn | |
| 133.7407 | Withdrawn | |
| 133.7501 | Withdrawn |
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 |
|---|---|
| K211785 | 2022-10-17 |
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.