510(k) Report

FDA applicant

Fixano SA

La Jolla, CA5 decisions2001–20020 recalls

FDA records 5 decisions for Fixano SA (La Jolla, CA) from 2001 to 2002: 5 510(k) clearances. Most are in product codes KTT (Appliance, Fixation, Nail/Blade/Plate…) and HTY (Pin, Fixation, Smooth). Its devices cite 7 predicates, 1 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 Fixano SA’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fixano SA since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Fixano SA 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?

  • KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component4decisions
  • HTYPin, Fixation, Smooth1decision

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K012062PF2Fixano SA · 20011cites it

What has FDA decided for it lately?

All 5 as Fixano SA →