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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
510(k) Number K190595
Device Name Signature ONE 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 Number888.3650
Classification Product Code
KWT  
Subsequent Product Codes
KWS   MBF   PHX   QHE  
Date Received03/07/2019
Decision Date 06/05/2019
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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