FDA applicant

Stabiliz Orthopaedics, Inc.

Exton, PA4 decisions2012–20260 recalls

FDA records 4 decisions for Stabiliz Orthopaedics, Inc. (Exton, PA) from 2012 to 2026: 4 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). Its devices cite 9 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Stabiliz Orthopaedics, LLC”.

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 Stabiliz Orthopaedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2012high 1 (2012) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Stabiliz Orthopaedics, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Stabiliz Orthopaedics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Stabiliz Orthopaedics, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?