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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, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K232371
Device Name Actinia® hip stems
Applicant
Implantcast GmbH
Lineburger Schanze 26
21614 Buxtehude,  DE
Applicant Contact Juliane Höppner
Correspondent
Implantcast GmbH
Luneburger Schanze 26
Buxtehude,  DE
Correspondent Contact Juliane Hoppner
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWY   MEH  
Date Received08/08/2023
Decision Date 10/19/2023
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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