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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
Zimmer GmbH
Sulzer Allee 8
Winterthur,  CH 8404
Applicant Contact Roberto Tommasini
Zimmer, Inc.
1800 West Center Street
Warsaw,  IN  46580
Correspondent Contact Dalene Binkley
Regulation Number888.3660
Classification Product Code
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