XIA 4.5 SPINAL SYSTEM

Growing Rod 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.

Pre-market Notification Details

Device IDK142114
510k NumberK142114
Device Name:XIA 4.5 SPINAL SYSTEM
ClassificationGrowing Rod System
Applicant STRYKER CORPORATION 2 PEARL COURT Allendale,  NJ  07401
ContactGarry T Hayeck, Ph.d.
CorrespondentGarry T Hayeck, Ph.d.
STRYKER CORPORATION 2 PEARL COURT Allendale,  NJ  07401
Product CodePGM  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-04
Decision Date2014-10-27
Summary:summary

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