Idys® C ZP 3DTi— 510(k) K240715

Name: FDA 510(k) clearance K240715
Creator: U.S. Food and Drug Administration
Published: 2024-03-22

Substantially Equivalent

Clariance

FDA 510(k) clearance K240715 for Idys® C ZP 3DTi, Substantially Equivalent on 2024-03-22. Applicant: Clariance. Device class: 2.

Clearance details

Applicant: Clariance
Product code: Code OVE
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2024-03-15
Decision date: 2024-03-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Beaurains, FR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

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.