SiJoin®T3— 510(k) K213815

Name: FDA 510(k) clearance K213815
Creator: U.S. Food and Drug Administration
Published: 2023-03-29

Substantially Equivalent

Vgi Medical, Inc.

FDA 510(k) clearance K213815 for SiJoin®T3, Substantially Equivalent on 2023-03-29. Applicant: Vgi Medical, Inc.. Device class: 2.

Clearance details

Applicant: Vgi Medical, Inc.
Product code: Code OUR
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2021-12-07
Decision date: 2023-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Largo, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OUR

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K261381 — TiLink-L SI Joint Fusion System2026-08-24
K260477 — CATAMARAN SI Joint Fusion System2026-04-08
K253488 — iFuse INTRA Ti Implant System2026-02-11
K253611 — Falco Fusion System2026-01-29
K252834 — Sacroiliac Joint Truss System (SJTS)2026-01-28

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.