Ocata 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 Ocata Anterior Cervical System.

Pre-market Notification Details

• Device ID: K170342
• 510k Number: K170342
• Device Name: Ocata Anterior Cervical System
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: Kalitec Direct, LLC 618 E. South Street Suite 500 Orlando, FL 32801
• Contact: Scott Winn
• Correspondent: J.d. Webb; The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-02-03
• Decision Date: 2017-05-09
• Summary: summary