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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 K230567
Device Name OptiVu™ ROSA® MxR
Applicant
Orthosoft Inc. (d/b/a Zimmer CAS)
75 Queen Street Suite 3300
Montreal,  CA H3C 2N6
Applicant Contact Mona Mansouri
Correspondent
Orthosoft Inc. (d/b/a Zimmer CAS)
75 Queen Street Suite 3300
Montreal,  CA H3C 2N6
Correspondent Contact Mona Mansouri
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Code
LLZ  
Date Received03/01/2023
Decision Date 06/13/2023
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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