510(k) Report

FDA applicant

Serrano Intl.

Mchenry, IL6 decisions1981–19850 recalls

FDA records 6 decisions for Serrano Intl. (Mchenry, IL) from 1981 to 1985: 6 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and HSB (Rod, Fixation, Intramedullary And Accessories). 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 Serrano Intl.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Serrano Intl. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Serrano Intl. 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?

  • HWCScrew, Fixation, Bone2decisions
  • HSBRod, Fixation, Intramedullary And Accessories1decision
  • FTMMesh, Surgical1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K810205Mecron Cancellous Cannulated Bone ScrewsSerrano Intl. · 19811cites it

What has FDA decided for it lately?

  • K851409Uniloc Total Hip ProsthesisSerrano Intl. · 1985
  • K820899Mecron Voorhoeve Titanium SheathSerrano Intl. · 1982
  • K820619Mecron (R) Acetabular Nets TMSerrano Intl. · 1982
  • K820852Mecron Concavex Flexible IntramedullarySerrano Intl. · 1982
  • K810497Bone Fixaction ScrewSerrano Intl. · 1981
  • K810205Mecron Cancellous Cannulated Bone ScrewsSerrano Intl. · 1981

All 6 as Serrano Intl. →