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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 K260104
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 Received01/13/2026
Decision Date 02/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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