Advanced MyHip Planner— 510(k) K221725

Substantially Equivalent

Medacta International S.A.

FDA 510(k) clearance K221725 for Advanced MyHip Planner, Substantially Equivalent on 2023-01-20. Applicant: Medacta International S.A..

Clearance details

Applicant
Medacta International S.A.
Product code
Code LLZ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Castel San Pietro (Ch), CH
Download summary PDFView on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ
Death
13
Total
13

Source: openFDA MAUDE database, through . 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.