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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cement obturator
510(k) Number K220838
Device Name Artisan Bone Plug, Universal Cement Restrictor
Applicant
Howmedica Osteonics, dba Stryker Orthopaedics
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact Margaret Klippel
Correspondent
Howmedica Osteonics, dba Stryker Orthopaedics
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact Margaret Klippel
Regulation Number878.3300
Classification Product Code
LZN  
Subsequent Product Code
JDI  
Date Received03/22/2022
Decision Date 05/20/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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