EXPEDIUM Spine System/Synapse System

Appliance, Fixation, Spinal Interlaminal

JOHNSON AND JOHNSON

The following data is part of a premarket notification filed by Johnson And Johnson with the FDA for Expedium Spine System/synapse System.

Pre-market Notification Details

Device IDK142460
510k NumberK142460
Device Name:EXPEDIUM Spine System/Synapse System
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant JOHNSON AND JOHNSON 325 PARAMOUNT DR. Raynham,  MA  02767
ContactJaclyn Porsolt
CorrespondentJaclyn Porsolt
JOHNSON AND JOHNSON 325 PARAMOUNT DR. Raynham,  MA  02767
Product CodeKWP  
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-02
Decision Date2014-10-01
Summary:summary

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