FDA applicant

Scandius Biomedical, Inc.

Littleton, MA6 decisions2004–20060 recalls

FDA records 6 decisions for Scandius Biomedical, Inc. (Littleton, MA) from 2004 to 2006: 6 510(k) clearances. Most are in product codes MAI (Fastener, Fixation, Biodegradable, Soft Tissue) and 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 Scandius Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Scandius Biomedical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Scandius Biomedical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Scandius Biomedical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?