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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 K260037
Device Name implantcast Packaging System Update
Applicant
Implantcast GmbH
Lüneburger Schanze 26
Buxtehude,  DE 21614
Applicant Contact Juliane Höppner
Correspondent
Mcra, LLC
803 7th St. NW, 3rd Floor
Washington,  DC  20001
Correspondent Contact Ryan Sexton
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
HSD   HSX   JDI   JWH   KWT  
KWY   MEH   OQI   PHX  
Date Received01/06/2026
Decision Date 03/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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