SYNTHES VECTRA SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

SYNTHES SPINE CO.LP

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

Pre-market Notification Details

Device IDK050451
510k NumberK050451
Device Name:SYNTHES VECTRA SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester,  PA  19380
ContactSusan Lewandowski
CorrespondentSusan Lewandowski
SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester,  PA  19380
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-02-22
Decision Date2005-03-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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