Simmetry
Simmetry Lag Implant 10.5 mm x 105 mm
3manufacturers in China registered for this device type
123catalogue 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 | Sivantage, United States |
|---|---|
| FDA product code | OUR |
| Device type | Sacroiliac Joint Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Premarket notification | Exempt |
| Record published | 2025-02-19 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B | 10.5 mm x 100 mm | In distribution |
| B | 10.5 mm x 95 mm | In distribution |
| B | 10.5 mm x 105 mm | In distribution |
| B | 14.5 mm x 100 mm | In distribution |
| B | 12.5 mm x 95 mm | In distribution |
| B | 8.5 mm x 60 mm | In distribution |
| B | 14.5 mm x 50 mm | In distribution |
| B | 10.5 mm x 45 mm | In distribution |
| B | 10.5 mm x 55 mm | In distribution |
| B | 8.5 mm x 65 mm | In distribution |
| B | 8.5 mm x 55 mm | In distribution |
| B | 8.5 mm x 95 mm | In distribution |
| B | 8.5 mm x 80 mm | In distribution |
| B | 10.5 mm x 70 mm | In distribution |
| B | 14.5 mm x 80 mm | In distribution |
| B | 8.5 mm x 65 mm | In distribution |
| B | 14.5 mm x 85 mm | In distribution |
| B | 14.5 mm x 95 mm | In distribution |
| B | 12.5 mm x 70 mm | In distribution |
| B | 12.5 mm x 75 mm | In distribution |
| B | 10.5 mm x 60 mm | In distribution |
| B | 10.5 mm x 60 mm | In distribution |
| B | 12.5 mm x 50 mm | In distribution |
| B | 12.5 mm x 45 mm | In distribution |
| B | 8.5 mm x 85 mm | In distribution |
| B | 10.5 mm x 110 mm | In distribution |
| B | 10.5 mm x 105 mm | In distribution |
| B | 8.5 mm x 90 mm | In distribution |
| B | 8.5 mm x 55 mm | In distribution |
| B | 14.5 mm x 50 mm | In distribution |
| B | 10.5 mm x 50 mm | In distribution |
| B | 8.5 mm x 100 mm | In distribution |
| B | 8.5 mm x 105 mm | In distribution |
| B | 12.5 mm x 60 mm | In distribution |
| B | 8.5 mm x 50 mm | In distribution |
| B | 8.5 mm x 105 mm | In distribution |
| B | 8.5 mm x 45 mm | In distribution |
| B | 8.5 mm x 35 mm | In distribution |
| B | 10.5 mm | In distribution |
| B | 14.5 mm x 65 mm | In distribution |
| B | 12.5 mm x 80 mm | In distribution |
| B | 14.5 mm x 60 mm | In distribution |
| B | 12.5 mm x 50 mm | In distribution |
| B | 14.5 mm x 85 mm | In distribution |
| B | 8.5 mm x 80 mm | In distribution |
| B | 12.5 mm x 85 mm | In distribution |
| B | 14.5 mm x 40 mm | In distribution |
| B | 10.5 mm x 35 mm | In distribution |
| B | In distribution | |
| B | 14.5 mm x 70 mm | In distribution |
| B | 8.5mm x 40mm | In distribution |
| B | 8.5 mm x 75 mm | In distribution |
| B | 14.5 mm x 75 mm | In distribution |
| B | 12.5 mm x 85 mm | In distribution |
| B | 12.5 mm x 90 mm | In distribution |
| B | 14.5 mm x 110 mm | In distribution |
| B | 10.5 mm x 70 mm | In distribution |
| B | 8.5 mm x 100 mm | In distribution |
| B | 12.5 mm x 40 mm | In distribution |
| B | 12.5 mm x 60 mm | In distribution |
| B | 14.5 mm x 95 mm | In distribution |
| B | 14.5 mm x 90 mm | In distribution |
| B | 12.5 mm | In distribution |
| B | 14.5 mm x 55 mm | In distribution |
| B | 12.5 mm x 105 mm | In distribution |
| B | 12.5 mm x 100 mm | In distribution |
| B | 14.5 mm x 80 mm | In distribution |
| B | 8.5 mm | In distribution |
| B | 10.5 mm x 85 mm | In distribution |
| B | In distribution | |
| B | 14.5 mm x 105 mm | In distribution |
| B | 8.5 mm x 30 mm | In distribution |
| B | 8.5 mm x 95 mm | In distribution |
| B | 14.5 mm x 100 mm | In distribution |
| B | 8.5 mm x 75 mm | In distribution |
| B | 10.5 mm x 65 mm | In distribution |
| B | 8.5 mm x 110 mm | In distribution |
| B | 12.5 mm x 105 mm | In distribution |
| B | 12.5 mm x 110 mm | In distribution |
| B | 10.5 mm x 95 mm | In distribution |
| B | 10.5 mm x 110 mm | In distribution |
| B | 10.5 mm x 30 mm | In distribution |
| B | 12.5 mm x 80 mm | In distribution |
| B | 14.5 mm x 110 mm | In distribution |
| B | 14.5 mm x 30 mm | In distribution |
| B | 10.5 mm x 90 mm | In distribution |
| B | 12.5 mm x 75 mm | In distribution |
| B | 8.5 mm x 50 mm | In distribution |
| B | 10.5 mm x 85 mm | In distribution |
| B | 8.5 mm x 60 mm | In distribution |
| B | 12.5 mm x 65 mm | In distribution |
| B | 12.5 mm x 55 mm | In distribution |
| B | 10.5 mm x 55 mm | In distribution |
| B | 10.5 mm x 75 mm | In distribution |
| B | 14.5 mm x 45 mm | In distribution |
| B | 12.5 mm x 70 mm | In distribution |
| B | 12.5 mm x 65 mm | In distribution |
| B | 10.5 mm x 80 mm | In distribution |
| B | 10.5 mm x 80 mm | In distribution |
| B | 10.5 mm x 90 mm | In distribution |
| B | 14.5 mm x 65 mm | In distribution |
| B | 12.5 mm x 95 mm | In distribution |
| B | 10.5 mm x 50 mm | In distribution |
| B | 8.5 mm x 85 mm | In distribution |
| B | 12.5 mm x 110 mm | In distribution |
| B | 14.5 mm | In distribution |
| B | 10.5 mm x 40 mm | In distribution |
| B | 10.5 mm x 65 mm | In distribution |
| B | 14.5 mm x 55 mm | In distribution |
| B | 14.5 mm x 75 mm | In distribution |
| B | 10.5 mm x 90 mm | In distribution |
| B | 14.5 mm x 70 mm | In distribution |
| B | 12.5 mm x 55 mm | In distribution |
| B | 8.5 mm x 70 mm | In distribution |
| B | 12.5 mm x 35 mm | In distribution |
| B | 12.5 mm x 30 mm | In distribution |
| B | 14.5 mm x 105 mm | In distribution |
| B | 14.5 mm x 60 mm | In distribution |
| B | 12.5 mm x 100 mm | In distribution |
| B | 12.5 mm x 90 mm | In distribution |
| B | 8.5 mm x 70 mm | In distribution |
| B | 14.5 mm x 90 mm | In distribution |
| B | 10.5 mm x 75 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 |
| Dynamis™ Implant System | Promethean Restorative Inc. | 120 |
Showing 12 of 534. All products under Sacroiliac Joint Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250647 | 2025-07-29 |
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.