MSFX Mikron Cervical Anterior Plate System— 510(k) K240484

Substantially Equivalent

Mikron Makina Sanayi VE Ticaret Ltd. Sti.

FDA 510(k) clearance K240484 for MSFX Mikron Cervical Anterior Plate System, Substantially Equivalent on 2024-04-17. Applicant: Mikron Makina Sanayi VE Ticaret Ltd. Sti..

Clearance details

Applicant: Mikron Makina Sanayi VE Ticaret Ltd. Sti.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2024-02-20
Decision date: 2024-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ivedik, TR

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.