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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 K172275
Device Name Vitality® Spinal Fixation System, Vitality®+ Power Instrument System
Applicant
Zimmer Biomet Spine, Inc.
10225 Westmoor Drive
Westminster,  CO  80021
Applicant Contact Kelly Stratton
Correspondent
Zimmer Biomet Spine, Inc.
10225 Westmoor Drive
Westminster,  CO  80021
Correspondent Contact Kelly Stratton
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ  
Date Received07/28/2017
Decision Date 09/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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