Idys® LIF— 510(k) K243670

Substantially Equivalent

Clariance

FDA 510(k) clearance K243670 for Idys® LIF, Substantially Equivalent on 2024-12-31. Applicant: Clariance.

Clearance details

Applicant: Clariance
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2024-11-27
Decision date: 2024-12-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Beaurains, FR

Download summary PDF View on FDA.gov ↗

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.