Idys-C ZP 3DTi— 510(k) K212562

Substantially Equivalent

Clariance, SA

FDA 510(k) clearance K212562 for Idys-C ZP 3DTi, Substantially Equivalent on 2021-10-12. Applicant: Clariance, SA.

Clearance details

Applicant: Clariance, SA
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2021-08-13
Decision date: 2021-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaurains, FR

Download summary PDF View on FDA.gov ↗

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.