ACRON™ TLIF System

Intervertebral Fusion Device With Bone Graft, Lumbar

SpineMED Ges.m.b.H

The following data is part of a premarket notification filed by Spinemed Ges.m.b.h with the FDA for Acron™ Tlif System.

Pre-market Notification Details

• Device ID: K171151
• 510k Number: K171151
• Device Name: ACRON™ TLIF System
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: SpineMED Ges.m.b.H Twarochgasse 11 Wien, AT A-1170
• Contact: Andreas Bernegger
• Correspondent: John Kapitan; Kapstone Medical, LLC PO Box 969 Leicester, NC 28748
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-04-20
• Decision Date: 2018-04-27
• Summary: summary