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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 K181744
Device Name BI-MENTUM dual mobility system
Applicant
Serf
85 Avenue des Bruyeres
Decines,  FR 69150
Applicant Contact Jean-Lus Aurelle
Correspondent
Gloster Biomedical International
577 N Hope Avenue
Santa Barbara,  CA  93110
Correspondent Contact Catherine Gloster
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
MEH  
Date Received07/02/2018
Decision Date 12/11/2018
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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