510(k) Report

FDA applicant

Laura Cattabriga

N. Bay Village, FL2 decisions2014–20140 recalls

FDA records 2 decisions for Laura Cattabriga (N. Bay Village, FL) in 2014: 2 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). Its devices cite 4 predicates, 0 of them its own earlier devices. 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 Laura Cattabriga’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2014: 2
2014high 2 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Laura Cattabriga by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HRSPlate, Fixation, Bone1decision
  • HWCScrew, Fixation, Bone1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K130614Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga · 20141cites it
  • K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga · 20141cites it

What has FDA decided for it lately?

  • K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga · 2014
  • K130614Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga · 2014

All 2 as Laura Cattabriga →