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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 K190766
Device Name PALACOS fast R+G
Applicant
Heraeus Medical GmbH
Philipp-Reis-Strasse 8/13
Wehrheim,  DE 61273
Applicant Contact Ute Greiner
Correspondent
Heraeus Medical GmbH
Philipp-Reis-Strasse 8/13
Wehrheim,  DE 61273
Correspondent Contact Ute Greiner
Regulation Number888.3027
Classification Product Code
LOD  
Subsequent Product Code
MBB  
Date Received03/25/2019
Decision Date 05/31/2019
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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