XIA 4.5 Spinal Fixation System, Power Adaaptor 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 Fixation System, Power Adaaptor Instrument Accessory.

Pre-market Notification Details

Device IDK152632
510k NumberK152632
Device Name:XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory
ClassificationThoracolumbosacral Pedicle Screw System
Applicant STRYKER CORPORATION 2 PEARL COURT Allendale,  NJ  07401
ContactSoraya King
CorrespondentSoraya King
STRYKER CORPORATION 2 PEARL COURT Allendale,  NJ  07401
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
Subsequent Product CodeOSH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-15
Decision Date2015-12-02
Summary:summary

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