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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 K171907
Device Name Vitality® Spinal Fixation 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 Received06/26/2017
Decision Date 07/14/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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