510(k) Report

FDA applicant

Neos Surgery S.L

Barcelona, ES6 decisions2010–20240 recalls

FDA records 6 decisions for Neos Surgery S.L (Barcelona, ES) from 2010 to 2024: 6 510(k) clearances. Most are in product codes GXR (Cover, Burr Hole) and JDQ (Cerclage, Fixation). Its devices cite 10 predicates, 4 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, neurology panel, where it files most

How often FDA has decided Neos Surgery S.L’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2010: 12013: 12016: 12022: 22024: 1
2010high 2 (2022) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Neos Surgery S.L by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GXRCover, Burr Hole4decisions
  • JDQCerclage, Fixation2decisions

Whose devices does it build on?

Its devices cite 10 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 4 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.

  • K132044Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation SystemNeos Surgery S.L · 20133cite it
  • K211613Stern Fix Sternal Stabilization SystemNeos Surgery S.L · 20221cites it
  • K160739Cranial COVERNeos Surgery S.L · 20161cites it
  • K101235Cranial Loop Cranial Bone Fixation SystemNeos Surgery S.L · 20101cites it

What has FDA decided for it lately?

  • K240137Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemNeos Surgery S.L · 2024
  • K221795STERN FIX Sternal Stabilization SystemNeos Surgery S.L · 2022
  • K211613Stern Fix Sternal Stabilization SystemNeos Surgery S.L · 2022
  • K160739Cranial COVERNeos Surgery S.L · 2016
  • K132044Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation SystemNeos Surgery S.L · 2013
  • K101235Cranial Loop Cranial Bone Fixation SystemNeos Surgery S.L · 2010

All 6 as Neos Surgery S.L →