Lateralized Glenosphere— 510(k) K193175

Substantially Equivalent

Medacta Inernational SA

FDA 510(k) clearance K193175 for Lateralized Glenosphere, Substantially Equivalent on 2020-08-11. Applicant: Medacta Inernational SA.

Clearance details

Applicant: Medacta Inernational SA
Product code: Code PHX
Advisory panel: Orthopedic
Date received: 2019-11-18
Decision date: 2020-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castel San Pietro (Ch), CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code PHX

product code PHX

Death: 10
Injury: 9,705
Malfunction: 1,252
Total: 10,967

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.