Centurion POCT System— 510(k) K180025

Substantially Equivalent

Orthofix, Inc.

FDA 510(k) clearance K180025 for Centurion POCT System, Substantially Equivalent on 2018-01-22. Applicant: Orthofix, Inc..

Clearance details

Applicant: Orthofix, Inc.
Product code: Code NKG
Advisory panel: Orthopedic
Date received: 2018-01-03
Decision date: 2018-01-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Lewisville, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKG

product code NKG

Death: 15
Injury: 1,090
Malfunction: 529
Total: 1,634

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.