510(k) K261352— 2D Hip Planning Software

Substantially Equivalent

One Ortho

Clearance details

Applicant: One Ortho
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2026-04-24
Decision date: 2026-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint-Genis-Laval, FR

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.