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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03700780627141	K172083	000
03700780626137	K172083	000
03700780626144	K172083	000
03700780626168	K172083	000
03700780626175	K172083	000
03700780626182	K172083	000
03700780626199	K172083	000
03700780626205	K172083	000
03700780626212	K172083	000
03700780626113	K172083	000
03700780626106	K172083	000
03700780625888	K172083	000
03700780625949	K172083	000
03700780625963	K172083	000
03700780625987	K172083	000
03700780626007	K172083	000
03700780626045	K172083	000
03700780626069	K172083	000
03700780626090	K172083	000
03700780626731	K172083	000
03700780626748	K172083	000
03700780626908	K172083	000
03700780626915	K172083	000
03700780626953	K172083	000
03700780626984	K172083	000
03700780627066	K172083	000
03700780627080	K172083	000
03700780627097	K172083	000
03700780627134	K172083	000
03700780626892	K172083	000
03700780626861	K172083	000
03700780626755	K172083	000
03700780626779	K172083	000
03700780626786	K172083	000
03700780626793	K172083	000
03700780626809	K172083	000
03700780626816	K172083	000
03700780626823	K172083	000
03700780626854	K172083	000
03700780625864	K172083	000