Renovis Anterior Cervical Plate System

Appliance, Fixation, Spinal Intervertebral Body

Renovis Surgical Technologies, Inc.

The following data is part of a premarket notification filed by Renovis Surgical Technologies, Inc. with the FDA for Renovis Anterior Cervical Plate System.

Pre-market Notification Details

• Device ID: K152193
• 510k Number: K152193
• Device Name: Renovis Anterior Cervical Plate System
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: Renovis Surgical Technologies, Inc. 1901 W. Lugonia Ave, Suite 340 Redlands, CA 92374
• Contact: Anthony Debenedictis
• Correspondent: Sharyn Orton; MEDIcept Inc. 200 Homer Ave Ashland, MA 01721
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-08-05
• Decision Date: 2015-09-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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