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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 K203532
Device Name BI-MENTUM™ ALTRX® Dual Mobility Liner
Applicant
Depuy Ireland UC
Loughbeg Ringaskiddy
Cork,  IE
Applicant Contact Erin Combs
Correspondent
Depuy Ireland UC
Loughbeg Ringaskiddy
Cork,  IE
Correspondent Contact Floriane Heinrich
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
MEH  
Date Received12/02/2020
Decision Date 04/28/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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