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

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..

Clearance details

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

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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.