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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
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