510(k) K211892— ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)

Substantially Equivalent

Arftx Medical, LLC

Clearance details

Applicant: Arftx Medical, LLC
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2021-06-21
Decision date: 2022-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.