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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
Recalls CDRH Recalls
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