XIA 3 SPINAL SYSTEM

Thoracolumbosacral Pedicle Screw System

STRYKER SPINE

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

Pre-market Notification Details

Device IDK083393
510k NumberK083393
Device Name:XIA 3 SPINAL SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant STRYKER SPINE 2 PEARL COURT Allendale,  NJ  07401
ContactCurtis Truesdale
CorrespondentCurtis Truesdale
STRYKER SPINE 2 PEARL COURT Allendale,  NJ  07401
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-11-17
Decision Date2009-04-01
Summary:summary

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