XIA® 4.5 Spinal System, 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® 4.5 Spinal System, Power Adaptor Instrument Accessory.

Pre-market Notification Details

Device IDK172724
510k NumberK172724
Device Name:XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Stryker Corporation 2 Pearl Court Allendale,  NJ  07401
ContactPriyanka Patel
CorrespondentPriyanka Patel
Stryker Corporation 2 Pearl Court Allendale,  NJ  07401
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-11
Decision Date2017-10-10
Summary:summary

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