Idys ALIF TiVac— 510(k) K191263

Substantially Equivalent

Clariance, Sas

FDA 510(k) clearance K191263 for Idys ALIF TiVac, Substantially Equivalent on 2019-06-06. Applicant: Clariance, Sas.

Clearance details

Applicant: Clariance, Sas
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2019-05-10
Decision date: 2019-06-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Beaurains, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.