LITe Plate System

Appliance, Fixation, Spinal Intervertebral Body

STRYKER CORP.

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

Pre-market Notification Details

Device IDK150449
510k NumberK150449
Device Name:LITe Plate System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant STRYKER CORP. 2 PEARL COURT Allendale,  NJ  07401
ContactGarry T. Hayeck
CorrespondentGarry T. Hayeck
STRYKER CORP. 2 PEARL COURT Allendale,  NJ  07401
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-20
Decision Date2015-03-20
Summary:summary

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