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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, Semi-Constrained, Metal/Polymer, Uncemented
510(k) Number K163397
Device Name SMR Hybrid Glenoid System
Applicant
Limacorporate S.p.A.
via Nazionale 52
Villanova di San Daniele,  IT 33038
Applicant Contact Michela Zanotto
Correspondent
Peoples & Associates Consulting LLC
5010 Lodge Pole Lane
Fort Wayne,  IN  46814
Correspondent Contact Stephen Peoples
Regulation Number888.3670
Classification Product Code
MBF  
Subsequent Product Codes
KWS   KWT   PHX  
Date Received12/05/2016
Decision Date 06/29/2017
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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