510(k) Report

FDA applicant

Mikron Makina Sanayi Ticaret Co., Ltd.

Ankara, TR1 decision2017–20170 recalls

FDA records 1 decision for Mikron Makina Sanayi Ticaret Co., Ltd. (Ankara, TR) in 2017: 1 510(k) clearance. All are in product code MNI (Orthosis, Spinal Pedicle Fixation). Its devices cite 2 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 Mikron Makina Sanayi Ticaret Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Mikron Makina Sanayi Ticaret Co., Ltd. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MNIOrthosis, Spinal Pedicle Fixation1decision

Whose devices does it build on?

Its devices cite 2 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.

  • K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 20171cites it

What has FDA decided for it lately?

  • K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017

The one decision as Mikron Makina Sanayi Ticaret Co., Ltd. →

Other applicant names beginning “Mikron”

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

Mikron Makina Sanayi VE Ticaret Ltd. Sti. 3Mikron Makina Sanayi VE Tic. Ltd. Sti. 1Mikron Makina San. ve Tic. Ltd. Sti. 1