Cyclops™ Anterior Cervical Plate System

Appliance, Fixation, Spinal Intervertebral Body

DeGen Medical

The following data is part of a premarket notification filed by Degen Medical with the FDA for Cyclops™ Anterior Cervical Plate System.

Pre-market Notification Details

• Device ID: K213901
• 510k Number: K213901
• Device Name: Cyclops™ Anterior Cervical Plate System
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: DeGen Medical 1321-C North Cashua Drive Florence, SC 29501
• Contact: Craig Black
• Correspondent: Linda Braddon; Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-12-14
• Decision Date: 2022-01-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842048150053	K213901	000
00842048150046	K213901	000