510(k) Report

FDA applicant

Schoening & Assoc., Inc.

Littleton, CO1 decision2003–20030 recalls

FDA records 1 decision for Schoening & Assoc., Inc. (Littleton, CO) in 2003: 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 Schoening & Assoc., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Schoening & Assoc., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Schoening & Assoc., Inc. 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 2 times; 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.

  • K030302HBS Headless Bone ScrewSchoening & Assoc., Inc. · 20032cite it

What has FDA decided for it lately?

  • K030302HBS Headless Bone ScrewSchoening & Assoc., Inc. · 2003

The one decision as Schoening & Assoc., Inc. →