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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 Cemented
510(k) Number K123122
Device Name GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)
Applicant
CLEVELAND CLINIC
10000 CEDAR AVENUE
CLEVELAND,  OH  44106
Applicant Contact STEPHEN J PEOPLES, VMD, MS
Correspondent
CLEVELAND CLINIC
10000 CEDAR AVENUE
CLEVELAND,  OH  44106
Correspondent Contact STEPHEN J PEOPLES, VMD, MS
Regulation Number888.3660
Classification Product Code
KWS  
Date Received10/04/2012
Decision Date 04/05/2013
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
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