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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 K142381
Device Name Xia 3 Spinal System
Applicant
Stryker Corp.
2 Pearl Court
Allendale,  NJ  07401
Applicant Contact GARRY T HAYECK
Correspondent
Stryker Corp.
2 Pearl Court
Allendale,  NJ  07401
Correspondent Contact GARRY T HAYECK
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI   OSH  
Date Received08/26/2014
Decision Date 10/21/2014
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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