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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 K170496
Device Name Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory
Applicant
Stryker Corporation
2 Pearl Court
Allendale,  NJ  07401
Applicant Contact Meriam Gabera
Correspondent
Stryker Corporation
2 Pearl Court
Allendale,  NJ  07401
Correspondent Contact Meriam Gabera, MS, RAC
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ  
Date Received02/17/2017
Decision Date 05/16/2017
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
Recalls CDRH Recalls
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