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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Arthroplasty Implantation System
510(k) Number K232425
Device Name Signature™ ONE System
Applicant
Orthosoft Inc. (D/B/A) Zimmer Cas)
75 Queen St., Suite 3300
Montreal,  CA H3C 2N6
Applicant Contact Nilam Dave
Correspondent
Orthosoft Inc. (D/B/A) Zimmer Cas)
75 Queen St., Suite 3300
Montreal,  CA H3C 2N6
Correspondent Contact Nilam Dave
Regulation Number888.3660
Classification Product Code
QHE  
Subsequent Product Codes
HSD   KWS   KWT   MBF   PHX  
Date Received08/11/2023
Decision Date 12/12/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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