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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 K241674
Device Name OSTEOPAL® V
Applicant
Heraeus Medical GmbH
Philipp-Reis-Str. 8/13
Wehrheim,  DE 61273
Applicant Contact Sarah Kopischke
Correspondent
Heraeus Medical GmbH
Philipp-Reis-Str. 8/13
Wehrheim,  DE 61273
Correspondent Contact Sarah Kopischke
Regulation Number888.3027
Classification Product Code
LOD  
Subsequent Product Code
NDN  
Date Received06/11/2024
Decision Date 12/05/2024
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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