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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 K210678
Device Name implaFit® hip stems
Applicant
Implantcast GmbH
Luneburger Schanze 26
Buxtehude,  DE
Applicant Contact Juliane Hoppner
Correspondent
MCRA, LLC
1050 K. St. NW
Suite 1000
Washington,  DC  20001
Correspondent Contact Dave McGurl
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDI   KWY  
Date Received03/05/2021
Decision Date 08/17/2022
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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