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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 K230116
Device Name Vital™ Spinal Fixation System
Applicant
Zimvie Spine (Zimmer Biomet Spine, Inc.)
10225 Westmoor Dr.
Westminister,  CO  80021
Applicant Contact Hanna Aucoin
Correspondent
Zimvie Spine (Zimmer Biomet Spine, Inc.)
10225 Westmoor Dr.
Westminister,  CO  80021
Correspondent Contact Hanna Aucoin
Regulation Number888.3070
Classification Product Code
NKB  
Date Received01/17/2023
Decision Date 10/11/2023
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
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