BowTie SI Joint Fusion System— 510(k) K232149

Name: FDA 510(k) clearance K232149
Creator: U.S. Food and Drug Administration
Published: 2024-04-20

Substantially Equivalent

Sail Fusion, LLC

FDA 510(k) clearance K232149 for BowTie SI Joint Fusion System, Substantially Equivalent on 2024-04-20. Applicant: Sail Fusion, LLC. Device class: 2.

Clearance details

Applicant: Sail Fusion, LLC
Product code: Code OUR
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2023-07-19
Decision date: 2024-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Del Mar, CA, 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.