Data / Medical devices / United States / Si-Technology, LLC
Si-Technology, LLC: FDA-registered device maker in Woodstock, GA, United States, 3 510(k) clearances
Si-Technology, LLC is registered with the FDA (registration 3012103114) in Woodstock, GA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 6, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012103114
- Address
- 7842 Hickory Flat Hwy, Woodstock, GA, United States, 30188
- Owner or operator
- SI-TECHNOLOGY, LLC (10050091)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- October 12, 2015
- Registered through
- 2026
- Brand names listed
- SI-TECHNOLOGY® SI-DESIS® SCREWS, SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sacroiliac Joint Fixation | OUR | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 6, 2025 | K251525 | SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System | OUR | Substantially Equivalent | Si-Technology, LLC | accessdata.fda.gov |
| August 13, 2024 | K241813 | SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System | OUR | Substantially Equivalent | Si-Technology, LLC | accessdata.fda.gov |
| August 12, 2015 | K151462 | SI-TECHNOLOGY® SI-DESIS® SCREWS | OUR | Substantially Equivalent | Si-Technology, LLC | accessdata.fda.gov |
Compare with other makers
Updated June 6, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.