Terrace™ Anterior Cervical Plate System

Appliance, Fixation, Spinal Intervertebral Body

CoreLink, LLC

The following data is part of a premarket notification filed by Corelink, Llc with the FDA for Terrace™ Anterior Cervical Plate System.

Pre-market Notification Details

• Device ID: K163104
• 510k Number: K163104
• Device Name: Terrace™ Anterior Cervical Plate System
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: CoreLink, LLC 7911 Forsyth Blvd, Suite # 200 St. Louis, MO 63105
• Contact: Stephan Jones
• Correspondent: Kenneth C. Maxwell; Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-11-07
• Decision Date: 2017-06-21
• Summary: summary