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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
510(k) Number K171858
Device Name Sidus Stem-Free Shoulder
Applicant
Zimmer GmbH
Sulzer Allee 8
Winterthur,  CH 8404
Applicant Contact Roberto Tommasini
Correspondent
Zimmer, Inc.
1800 W. Center St.
Warsaw,  IN  46580
Correspondent Contact Dalene Binkley
Regulation Number888.3660
Classification Product Code
PKC  
Date Received06/21/2017
Decision Date 12/18/2017
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
Recalls CDRH Recalls
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