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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 K192133
Device Name Zimmer Biomet Universal Navigation System
Applicant
Zimmer Biomet Spine, Inc.
10225 Westmoor Dr.
Westminister,  CO  80021
Applicant Contact Alex Pawlowski
Correspondent
Zimmer Biomet Spine, Inc.
10225 Westmoor Dr.
Westminister,  CO  80021
Correspondent Contact Alex Pawlowski
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Codes
HAW   KWP   KWQ   MNH   MNI  
NKB   OSH  
Date Received08/07/2019
Decision Date 10/29/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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