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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 K213708
Device Name ROSA® Knee System
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 Number882.4560
Classification Product Code
OLO  
Date Received11/24/2021
Decision Date 04/22/2022
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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