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 IDK113666
510k NumberK113666
Device Name:XIA 3 SPINAL SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant STRYKER SPINE 1331 H STREET NW 12TH FLOOR Washington,  DC  20005
ContactG. Stiegman
CorrespondentG. Stiegman
STRYKER SPINE 1331 H STREET NW 12TH FLOOR Washington,  DC  20005
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeMNH
Subsequent Product CodeMNI
Subsequent Product CodeOSH
CFR Regulation Number888.3070 [🔎]
DecisionSe - With Limitations (SESU)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-13
Decision Date2012-08-28
Summary:summary

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