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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 K240647
Device Name Virage® Navigation System
Applicant
Zimvie Spine (Zimmer Biomet Spine, Inc.)
10225 Westmoor Dr.
Westminister,  CO  80021
Applicant Contact Regan Ream
Correspondent
Zimvie Spine (Zimmer Biomet Spine, Inc.)
10225 Westmoor Dr.
Westminister,  CO  80021
Correspondent Contact Anjanet Mort
Regulation Number882.4560
Classification Product Code
OLO  
Date Received03/07/2024
Decision Date 04/05/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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