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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 K202475
Device Name PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G
Applicant
Heraeus Medical GmbH
Philipp-Reis-Str. 8/13
Wehrheim,  DE 61273
Applicant Contact Yannick Nils Hermanns
Correspondent
Heraeus Medical GmbH
Philipp-Reis-Str. 8/13
Wehrheim,  DE 61273
Correspondent Contact Yannick Nils Hermanns
Regulation Number888.3027
Classification Product Code
LOD  
Subsequent Product Codes
JDZ   KIH   MBB  
Date Received08/28/2020
Decision Date 11/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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