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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 K210263
Device Name Mpres Neck Preserving Stem
Applicant
MEDACTA INTERNATIONAL, SA
Strada Regina
Castel San Pietro,  CH CH-6874
Applicant Contact Stefano Baj
Correspondent
Medacta USA
3973 Delp Street
Memphis,  TN  83118
Correspondent Contact Chris Lussier
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
MEH  
Date Received02/01/2021
Decision Date 09/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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