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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, non-constrained, metal/polymer cemented
510(k) Number K222482
Device Name AGILON XO Shoulder System
Applicant
implantcast, GmbH
Luneburger Schanze 26
Buxtehude,  DE 21615
Applicant Contact Ms. Juliane Hoppner
Correspondent
MCRA, LLC
803 7th Street N.W., Floor 3
Washington,  DC  20001
Correspondent Contact Mr Dave McGurl
Regulation Number888.3650
Classification Product Code
KWT  
Subsequent Product Codes
HSD   PHX  
Date Received08/17/2022
Decision Date 09/28/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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