510(k) K222256— BonOs® Inject Bone Cement; NEO Pedicle Screw System

Substantially Equivalent

Neo Medical SA

Clearance details

Applicant: Neo Medical SA
Product code: Code PML
Advisory panel: Orthopedic
Date received: 2022-07-27
Decision date: 2022-08-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Villette (Lavaux), CH

Adverse events under product code PML

product code PML

Death: 8
Total: 8

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.