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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthopedic stereotaxic instrument
510(k) Number K213720
Device Name Vital Navigation System
Applicant
ZimVie (Zimmer Biomet Spine, Inc.)
10225 Westmoor Drive
Westminster,  CO  80021
Applicant Contact Hanna Aucoin
Correspondent
ZimVie (Zimmer Biomet Spine, Inc.)
10225 Westmoor Drive
Westminster,  CO  80021
Correspondent Contact Hanna Aucoin
Regulation Number882.4560
Classification Product Code
OLO  
Date Received11/24/2021
Decision Date 01/07/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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