Matira™ Anterior Cervical System

Appliance, Fixation, Spinal Intervertebral Body

Kalitec Direct, LLC

The following data is part of a premarket notification filed by Kalitec Direct, Llc with the FDA for Matira™ Anterior Cervical System.

Pre-market Notification Details

• Device ID: K172086
• 510k Number: K172086
• Device Name: Matira™ Anterior Cervical System
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: Kalitec Direct, LLC 618 E. South Street, Suite 500 Orlando, FL 32801
• Contact: Keith Cannan
• Correspondent: Justin Eggleton; Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street Northwest, Suite 1000 Washington, DC 20001
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-07-11
• Decision Date: 2017-09-22
• Summary: summary