Artus™ Cervical Plate System

Appliance, Fixation, Spinal Intervertebral Body

Ulrich GmbH & Co. KG

The following data is part of a premarket notification filed by Ulrich Gmbh & Co. Kg with the FDA for Artus™ Cervical Plate System.

Pre-market Notification Details

• Device ID: K202227
• 510k Number: K202227
• Device Name: Artus™ Cervical Plate System
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: Ulrich GmbH & Co. KG Buchbrunnenweg 12 Ulm, DE 89081
• Contact: Christoph Ulrich
• Correspondent: Hans Stover; Ulrich Medical USA 18221 Edison Avenue Chesterfield, MO 63005
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-08-07
• Decision Date: 2020-09-14