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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 K080928
Device Name XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS
Applicant
Stryker Spine
2 Pearl Court
Allendale,  NJ  07401
Applicant Contact CURTIS TRUESDALE
Correspondent
Stryker Spine
2 Pearl Court
Allendale,  NJ  07401
Correspondent Contact CURTIS TRUESDALE
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received04/02/2008
Decision Date 04/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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