510(k) Report

FDA applicant

Micomed Ortho GmbH

Lake Forest, CA2 decisions2002–20030 recalls

FDA records 2 decisions for Micomed Ortho GmbH (Lake Forest, CA) from 2002 to 2003: 2 510(k) clearances. Most are in product codes MNI (Orthosis, Spinal Pedicle Fixation) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). Its devices cite 6 predicates, 0 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 Micomed Ortho GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Micomed Ortho GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Micomed Ortho GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MNIOrthosis, Spinal Pedicle Fixation1decision
  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K024125Halm Zielke Instrumentation SystemMicomed Ortho GmbH · 20031cites it

What has FDA decided for it lately?

  • K024125Halm Zielke Instrumentation SystemMicomed Ortho GmbH · 2003
  • K021275Micomed Posterior Doublerod SystemMicomed Ortho GmbH · 2002

All 2 as Micomed Ortho GmbH →

Other applicant names beginning “Micomed”

FDA records each applicant name separately; these may or may not be the same firm.

Micomed GmbH 2