SI-TECHNOLOGY® SI-DESIS® SCREWS— 510(k) K151462

Name: FDA 510(k) clearance K151462
Creator: U.S. Food and Drug Administration
Published: 2015-08-12

Substantially Equivalent

Si-Technology, LLC

FDA 510(k) clearance K151462 for SI-TECHNOLOGY® SI-DESIS® SCREWS, Substantially Equivalent on 2015-08-12. Applicant: Si-Technology, LLC. Device class: 2.

Clearance details

Applicant: Si-Technology, LLC
Product code: Product code OUR
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2015-06-01
Decision date: 2015-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Collins, CO, US

Download summary PDF View on FDA.gov ↗

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K253611 — Falco Fusion System2026-01-29
K252834 — Sacroiliac Joint Truss System (SJTS)2026-01-28

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Adverse events under product code OUR

product code OUR

Death: 3
Injury: 347
Total: 350

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.