MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS— 510(k) K130073

Name: FDA 510(k) clearance K130073
Creator: U.S. Food and Drug Administration
Published: 2013-12-16

Substantially Equivalent

Mikron Makina Sanayi VE Ticaret Ltd. Sti.

FDA 510(k) clearance K130073 for MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS, Substantially Equivalent on 2013-12-16. Applicant: Mikron Makina Sanayi VE Ticaret Ltd. Sti.. Device class: 2.

Clearance details

Applicant: Mikron Makina Sanayi VE Ticaret Ltd. Sti.
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2013-01-11
Decision date: 2013-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chesapeake City, MD, US

Download summary PDF View on FDA.gov ↗

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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.