SYNAPSE SYSTEM, SYNTHES OC FUSION 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, Synthes Oc Fusion System.

Pre-market Notification Details

Device IDK141897
510k NumberK141897
Device Name:SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant SYNTHES USA PRODUCTS, LLC 325 PARAMOUNT DRIVE Rayham,  MA  02767
ContactMitch Ohiwa
CorrespondentMitch Ohiwa
SYNTHES USA PRODUCTS, LLC 325 PARAMOUNT DRIVE Rayham,  MA  02767
Product CodeKWP  
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-14
Decision Date2014-09-25
Summary:summary

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