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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 K182260
Device Name PALACOS MV
Applicant
Heraeus Medical GmbH
Philipp-Reis-Str. 8-13
Wehrheim,  DE 61273
Applicant Contact Ute Greiner
Correspondent
Heraeus Medical GmbH
Philipp-Reis-Str. 8-13
Wehrheim,  DE 61273
Correspondent Contact Ute Greiner
Regulation Number888.3027
Classification Product Code
LOD  
Date Received08/21/2018
Decision Date 09/17/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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