Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory

Thoracolumbosacral Pedicle Screw System

Stryker Corporation

The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory.

Pre-market Notification Details

Device IDK170496
510k NumberK170496
Device Name:Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Stryker Corporation 2 Pearl Court Allendale,  NJ  07401
ContactMeriam Gabera
CorrespondentMeriam Gabera, Ms, Rac
Stryker Corporation 2 Pearl Court Allendale,  NJ  07401
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-17
Decision Date2017-05-16
Summary:summary

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