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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K152632
Device Name XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory
Applicant
Stryker Corporation
2 Pearl Court
Allendale,  NJ  07401
Applicant Contact SORAYA KING
Correspondent
Stryker Corporation
2 Pearl Court
Allendale,  NJ  07401
Correspondent Contact SORAYA KING
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI   OSH  
Date Received09/15/2015
Decision Date 12/02/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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