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 IDK152193
510k NumberK152193
Device Name:Renovis Anterior Cervical Plate System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant Renovis Surgical Technologies, Inc. 1901 W. Lugonia Ave, Suite 340 Redlands,  CA  92374
ContactAnthony Debenedictis
CorrespondentSharyn Orton
MEDIcept Inc. 200 Homer Ave Ashland,  MA  01721
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-05
Decision Date2015-09-25
Summary:summary

NIH GUDID Devices

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