Zero-P Natural Plate System

Appliance, Fixation, Spinal Intervertebral Body

Synthes (USA), LLC

The following data is part of a premarket notification filed by Synthes (usa), Llc with the FDA for Zero-p Natural Plate System.

Pre-market Notification Details

Device IDK152239
510k NumberK152239
Device Name:Zero-P Natural Plate System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant Synthes (USA), LLC 1051 Synthes Ave Monument,  CO  80132
ContactBeth Becotte
CorrespondentLaura Bleyendaal
DePuy Synthes 325 Paramount Drive Raynham,  MA  02767
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-10
Decision Date2015-12-02
Summary:summary

NIH GUDID Devices

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