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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
Lima Corporate S.P.A.
Via Nazionale, 52
Villanova Di San Daniele Udine,  IT
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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