SYNAPSE SYSTEM

Appliance, Fixation, Spinal Interlaminal

SYNTHES USA PRODUCTS LLC

The following data is part of a premarket notification filed by Synthes Usa Products Llc with the FDA for Synapse System.

Pre-market Notification Details

Device IDK133698
510k NumberK133698
Device Name:SYNAPSE SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant SYNTHES USA PRODUCTS LLC 325 Paramount Drive Raynham,  MA  02767
ContactLaura Bleyendaal
CorrespondentLaura Bleyendaal
SYNTHES USA PRODUCTS LLC 325 Paramount Drive 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 Received2013-12-03
Decision Date2014-01-16
Summary:summary

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