510(k) Report

FDA applicant

Siats, LLC

Tulsa, OK1 decision2017–20170 recalls

FDA records 1 decision for Siats, LLC (Tulsa, OK) in 2017: 1 510(k) clearance. All are in product code OVD (Intervertebral Fusion Device With Integrated…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Siats, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Siats, LLC by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K170855T-Rex Standalone ALIFSiats, LLC · 20171cites it

What has FDA decided for it lately?

  • K170855T-Rex Standalone ALIFSiats, LLC · 2017

The one decision as Siats, LLC →