510(k) Report

FDA applicant

Koby Surgical

Houston, TX1 decision2006–20060 recalls

FDA records 1 decision for Koby Surgical (Houston, TX) in 2006: 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 Koby Surgical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Koby Surgical since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Koby Surgical 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 4 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.

  • K060026Koby Surgical Internal Fixation SystemKoby Surgical · 20064cite it

What has FDA decided for it lately?

  • K060026Koby Surgical Internal Fixation SystemKoby Surgical · 2006

The one decision as Koby Surgical →