TECTONIC CERVICAL PLATE SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

K2M, LLC

The following data is part of a premarket notification filed by K2m, Llc with the FDA for Tectonic Cervical Plate System.

Pre-market Notification Details

Device IDK051531
510k NumberK051531
Device Name:TECTONIC CERVICAL PLATE SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant K2M, LLC 751 MILLER DR.,S.E., SUITE F1 Leesburg,  VA  20175
ContactRich Woods
CorrespondentRich Woods
K2M, LLC 751 MILLER DR.,S.E., SUITE F1 Leesburg,  VA  20175
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-09
Decision Date2005-10-17
Summary:summary

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