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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 K212023
Device Name Virage Navigation System
Applicant
Zimmer Biomet Spine, Inc.
10225 Westmoor Drive
Westminster,  CO  80021
Applicant Contact David Pollard
Correspondent
Zimmer Biomet Spine, Inc.
10225 Westmoor Drive
Westminster,  CO  80021
Correspondent Contact David Pollard
Regulation Number882.4560
Classification Product Code
OLO  
Date Received06/29/2021
Decision Date 08/27/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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