SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System

Posterior Cervical Screw System

DEPUY SYNTHES, Inc.

The following data is part of a premarket notification filed by Depuy Synthes, Inc. with the FDA for Summit Si Oct Spinal Fixation System, Mountaineer Oct Spinal System.

Pre-market Notification Details

Device IDK151885
510k NumberK151885
Device Name:SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System
ClassificationPosterior Cervical Screw System
Applicant DEPUY SYNTHES, Inc. 325 Paramount Drive Raynham,  MA  02767
ContactKaren K Sylvia
CorrespondentLaura Bleyendaal
DePuy Synthes 325 Paramount Drive Raynham,  MA  02767
Product CodeNKG  
CFR Regulation Number888.3075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-09
Decision Date2015-09-03
Summary:summary

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