Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, Or -Oblique) Lumbar Interbody Fusion System

Intervertebral Fusion Device With Bone Graft, Lumbar

Vertera, Inc.

The following data is part of a premarket notification filed by Vertera, Inc. with the FDA for Coalesce™ (-straight, -convex, -crescent, -lateral, -anterior, Or -oblique) Lumbar Interbody Fusion System.

Pre-market Notification Details

• Device ID: K163506
• 510k Number: K163506
• Device Name: Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, Or -Oblique) Lumbar Interbody Fusion System
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: Vertera, Inc. 739 Trabert Ave. NW Suite F Atlanta, GA 30318
• Contact: Wei Allen Chang
• Correspondent: Wei Allen Chang; Vertera, Inc. 739 Trabert Ave. NW Suite F Atlanta, GA 30318
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-12-14
• Decision Date: 2017-06-19
• Summary: summary