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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 K200666
Device Name Stryker Xia 3 Power Adaptor
Stryker Spine
2 Pearl Court
Allendale,  NJ  07401
Applicant Contact Megan Callanan
Stryker Spine
2 Pearl Court
Allendale,  NJ  07401
Correspondent Contact Megan Callanan
Regulation Number888.3070
Classification Product Code
Date Received03/13/2020
Decision Date 04/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No