Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Si-Technology, LLC · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251525 | SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System | Si-Technology, LLC | 2025-06-06 | 18 | 0 |
| K241813 | SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System | Si-Technology, LLC | 2024-08-13 | 53 | 0 |
| K151462 | SI-TECHNOLOGY® SI-DESIS® SCREWS | Si-Technology, LLC | 2015-08-12 | 72 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda