Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System— 510(k) K241034

Substantially Equivalent

Medacta International S.A.

FDA 510(k) clearance K241034 for Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System, Substantially Equivalent on 2024-06-12. Applicant: Medacta International S.A..

Clearance details

Applicant: Medacta International S.A.
Product code: Code PML
Advisory panel: Orthopedic
Date received: 2024-04-16
Decision date: 2024-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castel San Pietro, CH

Download summary PDF View on FDA.gov ↗

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.