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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Cement
510(k) Number K202458
Device Name BonOs Inject, Pedicle screw kits, Cement pusher
Applicant
Osartis GmbH
Auf der Beune 101
Munster,  DE 64839
Applicant Contact Volker Stirnal
Correspondent
Osartis GmbH
Auf der Beune 101
Munster,  DE 64839
Correspondent Contact Volker Stirnal
Regulation Number888.3027
Classification Product Code
LOD  
Subsequent Product Codes
NDN   NKB   PML  
Date Received08/27/2020
Decision Date 05/18/2021
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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