Idys™ ALIF System— 510(k) K172083

Substantially Equivalent

Clariance, Sas

FDA 510(k) clearance K172083 for Idys™ ALIF System, Substantially Equivalent on 2017-11-08. Applicant: Clariance, Sas.

Clearance details

Applicant
Clariance, Sas
Product code
Code OVD
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Beaurains, FR
Download summary PDFView on FDA.gov ↗

Adverse events under product code OVD

product code OVD
Death
5
Injury
495
Total
500

Source: openFDA MAUDE database, through . 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.