510(k) Report

FDA applicant

Sc Medica

Strasbourg, FR3 decisions2024–20250 recalls

FDA records 3 decisions for Sc Medica (Strasbourg, FR) from 2024 to 2025: 3 510(k) clearances. All are in product code MRW (System, Facet Screw Spinal Device). Since 2016 its 510(k)s took a median of 268 days from receipt to decision, against 97 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 2 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

How often FDA has decided Sc Medica’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2024: 12025: 2
2024high 2 (2025) · low 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Sc Medica by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MRWSystem, Facet Screw Spinal Device3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 268 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 97 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K252153FFX Facet Fixation SystemSc Medica · 20252cite it
  • K232468SC Medica FFXSc Medica · 20241cites it

What has FDA decided for it lately?

  • K250679FFX Facet Fixation SystemSc Medica · 2025
  • K252153FFX Facet Fixation SystemSc Medica · 2025
  • K232468SC Medica FFXSc Medica · 2024

All 3 as Sc Medica →