Stryker Xia 3 Power Adaptor

Thoracolumbosacral Pedicle Screw System

Stryker Spine

The following data is part of a premarket notification filed by Stryker Spine with the FDA for Stryker Xia 3 Power Adaptor.

Pre-market Notification Details

Device IDK200666
510k NumberK200666
Device Name:Stryker Xia 3 Power Adaptor
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Stryker Spine 2 Pearl Court Allendale,  NJ  07401
ContactMegan Callanan
CorrespondentMegan Callanan
Stryker Spine 2 Pearl Court Allendale,  NJ  07401
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-13
Decision Date2020-04-23

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