Tiger® Occipital-Cervical-Thoracic Spinal Fixation System

Posterior Cervical Screw System

CoreLink, LLC

The following data is part of a premarket notification filed by Corelink, Llc with the FDA for Tiger® Occipital-cervical-thoracic Spinal Fixation System.

Pre-market Notification Details

• Device ID: K200863
• 510k Number: K200863
• Device Name: Tiger® Occipital-Cervical-Thoracic Spinal Fixation System
• Classification: Posterior Cervical Screw System
• Applicant: CoreLink, LLC 2072 Fenton Logistics Blvd. St. Louis, MO 63206
• Contact: Steve Mounts
• Correspondent: Nathan Wright; Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918
• Product Code: NKG
• CFR Regulation Number: 888.3075 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-04-01
• Decision Date: 2020-04-28