e-Ortho Shoulder Software— 510(k) K201928

Substantially Equivalent

FH Industrie

FDA 510(k) clearance K201928 for e-Ortho Shoulder Software, Substantially Equivalent on 2020-09-30. Applicant: FH Industrie.

Clearance details

Applicant: FH Industrie
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2020-07-10
Decision date: 2020-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quimper Finistere, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.