K200920

Substantially Equivalent

Idys ALIF ZP 3DTi

Applicant: Clariance, Sas
Product code: MAX
Advisory panel: Orthopedic
Date received: 2020-04-06
Decision date: 2020-05-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Beaurains, FR

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.