Hexanium® ACIF

Intervertebral Fusion Device With Integrated Fixation, Cervical

SpineVision SAS

The following data is part of a premarket notification filed by Spinevision Sas with the FDA for Hexanium® Acif.

Pre-market Notification Details

• Device ID: K193000
• 510k Number: K193000
• Device Name: Hexanium® ACIF
• Classification: Intervertebral Fusion Device With Integrated Fixation, Cervical
• Applicant: SpineVision SAS 10 Rue De La Renaissance Batiment E Antony, FR 92160
• Contact: Anaelle Gallego
• Correspondent: Sevrina Ciucci; Lince Consulting, LLC 111 Deerwood Road, Suite 200 San Ramon, CA 94583
• Product Code: OVE
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-10-28
• Decision Date: 2020-10-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03663136000220	K193000	000
03663136000374	K193000	000
03663136000381	K193000	000
03663136000398	K193000	000
03663136000404	K193000	000
03663136000411	K193000	000
03663136000428	K193000	000
03663136000435	K193000	000
03663136000459	K193000	000
03663136000527	K193000	000
03663136000534	K193000	000
03663136000541	K193000	000
03663136000558	K193000	000
03663136000367	K193000	000
03663136000350	K193000	000
03663136000237	K193000	000
03663136000244	K193000	000
03663136000251	K193000	000
03663136000268	K193000	000
03663136000275	K193000	000
03663136000282	K193000	000
03663136000299	K193000	000
03663136000305	K193000	000
03663136000312	K193000	000
03663136000329	K193000	000
03663136000336	K193000	000
03663136000343	K193000	000
03663136000565	K193000	000
03663136000572	K193000	000
03663136000725	K193000	000
03663136000732	K193000	000
03663136000749	K193000	000
03663136000756	K193000	000
03663136000763	K193000	000
03663136000770	K193000	000
03663136000787	K193000	000
03663136000794	K193000	000
03663136000800	K193000	000
03663136000817	K193000	000
03663136000824	K193000	000
03663136000831	K193000	000
03663136000718	K193000	000
03663136000701	K193000	000
03663136000589	K193000	000
03663136000596	K193000	000
03663136000602	K193000	000
03663136000619	K193000	000
03663136000626	K193000	000
03663136000633	K193000	000
03663136000640	K193000	000
03663136000657	K193000	000
03663136000664	K193000	000
03663136000671	K193000	000
03663136000688	K193000	000
03663136000695	K193000	000
03663136000442	K193000	000