510(k) Report

FDA applicant

O.M.T. Oberflachen-Und Materialtechnologie GmbH

Huntington, WV1 decision2004–20040 recalls

FDA records 1 decision for O.M.T. Oberflachen-Und Materialtechnologie GmbH (Huntington, WV) in 2004: 1 510(k) clearance. All are in product code HWC (Screw, Fixation, Bone). 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 O.M.T. Oberflachen-Und Materialtechnologie GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for O.M.T. Oberflachen-Und Materialtechnologie GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — O.M.T. Oberflachen-Und Materialtechnologie GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HWCScrew, Fixation, Bone1decision

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.

  • K042079Oss/(Scarf)- and Osw-ScrewO.M.T. Oberflachen-Und Materialtechnologie GmbH · 20041cites it

What has FDA decided for it lately?

  • K042079Oss/(Scarf)- and Osw-ScrewO.M.T. Oberflachen-Und Materialtechnologie GmbH · 2004

The one decision as O.M.T. Oberflachen-Und Materialtechnologie GmbH →