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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 K251314
Device Name Rosa® Knee System
Applicant
Orthosoft Inc. (d/b/a) Zimmer CAS
75 Queen St., Suite 3300
Montreal,  CA H3C 2N6
Applicant Contact Kruti Gosalia
Correspondent
Orthosoft Inc. (d/b/a) Zimmer CAS
75 Queen St., Suite 3300
Montreal,  CA H3C 2N6
Correspondent Contact Kruti Gosalia
Regulation Number882.4560
Classification Product Code
OLO  
Date Received04/28/2025
Decision Date 11/13/2025
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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