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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K220733
Device Name OptiVu ROSA MxR
Applicant
Orthosoft, Inc. (d/b/a Zimmer CAS)
75 Queen St., Suite 3300
Montreal,  CA H3C 2N6
Applicant Contact Paul Hardy
Correspondent
Orthosoft, Inc. (d/b/a Zimmer CAS)
75 Queen St., Suite 3300
Montreal,  CA H3C 2N6
Correspondent Contact Paul Hardy
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
OLO  
Date Received03/14/2022
Decision Date 07/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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