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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 K183550
Device Name Vitality® Spinal Fixation System
Applicant
Zimmer Biomet Spine, Inc.
10225 Westmoor Dr.
Westminister,  CO  80021
Applicant Contact Brendon Gareth Heyerdahl
Correspondent
Zimmer Biomet Spine, Inc.
10225 Westmoor Dr.
Westminister,  CO  80021
Correspondent Contact Brendon Gareth Heyerdahl
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ  
Date Received12/20/2018
Decision Date 04/08/2019
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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