SYNTHES VECTRA-ONE SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

SYNTHES SPINE

The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Vectra-one System.

Pre-market Notification Details

Device IDK071667
510k NumberK071667
Device Name:SYNTHES VECTRA-ONE SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant SYNTHES SPINE 1302 WRIGHTS LANE EAST West Chester,  PA  19380
ContactStacey Bonnell
CorrespondentStacey Bonnell
SYNTHES SPINE 1302 WRIGHTS LANE EAST West Chester,  PA  19380
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-06-19
Decision Date2007-11-30
Summary:summary

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