Idys™ ALIF System

Intervertebral Fusion Device With Integrated Fixation, Lumbar

CLARIANCE SAS

The following data is part of a premarket notification filed by Clariance Sas with the FDA for Idys™ Alif System.

Pre-market Notification Details

• Device ID: K172083
• 510k Number: K172083
• Device Name: Idys™ ALIF System
• Classification: Intervertebral Fusion Device With Integrated Fixation, Lumbar
• Applicant: CLARIANCE SAS 18 Rue Robespierre Beaurains, FR 62217
• Contact: Pascal Rokegem
• Correspondent: Janice M. Hogan; Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, PA 19103
• Product Code: OVD
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-07-10
• Decision Date: 2017-11-08
• Summary: summary