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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 K233199
Device Name ROSA® Shoulder System
Applicant
Orthosoft Inc (D/B/A Zimmer Cas)
75 Queen St., Suite 3300
Montreal,  CA H3C 2N6
Applicant Contact Sankalp Dere
Correspondent
Orthosoft Inc (D/B/A Zimmer Cas)
75 Queen St., Suite 3300
Montreal,  CA H3C 2N6
Correspondent Contact Sankalp Dere
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Code
LLZ  
Date Received09/28/2023
Decision Date 02/21/2024
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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