XIA SPINAL SYSTEM

Orthosis, Spinal Pedicle Fixation

STRYKER SPINE

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

Pre-market Notification Details

Device IDK053115
510k NumberK053115
Device Name:XIA SPINAL SYSTEM
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant STRYKER SPINE 2 PEARL COURT Allendale,  NJ  07401
ContactSimona Voic
CorrespondentSimona Voic
STRYKER SPINE 2 PEARL COURT Allendale,  NJ  07401
Product CodeMNI  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-11-07
Decision Date2005-12-06
Summary:summary

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