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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 West Center Street
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
Recalls CDRH Recalls
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