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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 K162068
Device Name ARROW Anatomical Porous glenoid
Applicant
Fournitures Hospitalieres Industrie
Zi De Kernevez – 6 Rue Nobel
Quimper,  FR 29000
Applicant Contact Patricia Donnard
Correspondent
Fournitures Hospitalieres Industrie
Zi De Kernevez – 6 Rue Nobel
Quimper,  FR 29000
Correspondent Contact Patricia Donnard
Regulation Number888.3670
Classification Product Code
MBF  
Subsequent Product Codes
KWS   KWT  
Date Received07/26/2016
Decision Date 04/10/2017
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
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