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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 K210121
Device Name ROSA Partial Knee System
Applicant
Orthosoft D/B/A Zimmer Cas
75 Queen St., Suite 3300
Montreal,  CA H3C 2N6
Applicant Contact Kavina Veeren
Correspondent
Orthosoft D/B/A Zimmer Cas
75 Queen St., Suite 3300
Montreal,  CA H3C 2N6
Correspondent Contact Kavina Veeren
Regulation Number882.4560
Classification Product Code
OLO  
Date Received01/19/2021
Decision Date 04/19/2021
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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