Mikron Spinal Fixation System— 510(k) K171497

Name: FDA 510(k) clearance K171497
Creator: U.S. Food and Drug Administration
Published: 2017-10-12

Substantially Equivalent

Mikron Makina Sanayi Ticaret Co. , Ltd.

FDA 510(k) clearance K171497 for Mikron Spinal Fixation System, Substantially Equivalent on 2017-10-12. Applicant: Mikron Makina Sanayi Ticaret Co. , Ltd.. Device class: 2.

Clearance details

Applicant: Mikron Makina Sanayi Ticaret Co. , Ltd.
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2017-05-22
Decision date: 2017-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ankara, TR

Download summary PDF View on FDA.gov ↗

Recent devices under product code MNI

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K160731 — LumFix Spinal Fixation Sytem2016-10-04
K151458 — Double Medical Universal Spine System2016-08-22
K153273 — MySpine Pedicle Screw Placement Guides - LP2016-06-29
K160124 — LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System2016-04-04
K160320 — Premier2016-04-01

Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.