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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
510(k) Number K191569
Device Name Implantcast ic-Bipolar Head System
Applicant
Implantcast GmbH
Luneburger Schanze 26
Buxtehude,  DE 21614
Applicant Contact Juliiane Hoppner
Correspondent
Mcra, LLC
1050 K. St. NW
Suite 1000
Washington,  DC  20001
Correspondent Contact Dave McGurl
Regulation Number888.3390
Classification Product Code
KWY  
Subsequent Product Codes
LZO   MEH  
Date Received06/13/2019
Decision Date 08/28/2019
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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