LITe Plate System

Appliance, Fixation, Spinal Intervertebral Body

STRYKER CORPORATION

The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Lite Plate System.

Pre-market Notification Details

Device IDK142699
510k NumberK142699
Device Name:LITe Plate System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant STRYKER CORPORATION 2 PEARL COURT Allendale,  NJ  07401
ContactKristen Meany
CorrespondentGarry T Hayeck
STRYKER CORPORATION 2 PEARL COURT Allendale,  NJ  07401
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-22
Decision Date2014-12-31
Summary:summary

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