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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 K150119
Device Name PALACOS R pro
Applicant
Heraeus Medical GmbH
Philipp-Reis-Str. 8-13
Wehrheim,  DE 61273
Applicant Contact ASTRID MARX
Correspondent
Icon Plc
62 Forest St., Suite 300
Marlborough,  MA  01752
Correspondent Contact Tina Wu-Murphy
Regulation Number888.3027
Classification Product Code
LOD  
Subsequent Product Codes
JDZ   KIH  
Date Received01/20/2015
Decision Date 06/17/2015
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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