BI-MENTUM™ ALTRX® Dual Mobility Liner

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

Depuy Ireland UC

The following data is part of a premarket notification filed by Depuy Ireland Uc with the FDA for Bi-mentum™ Altrx® Dual Mobility Liner.

Pre-market Notification Details

Device IDK203532
510k NumberK203532
Device Name:BI-MENTUM™ ALTRX® Dual Mobility Liner
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant Depuy Ireland UC Loughbeg Ringaskiddy Co. Cork,  IE
ContactErin Combs
CorrespondentFloriane Heinrich
Depuy Ireland UC Loughbeg Ringaskiddy Co. Cork,  IE
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-02
Decision Date2021-04-28

Trademark Results [BI-MENTUM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BI-MENTUM
BI-MENTUM
87672999 not registered Live/Pending
Depuy Synthes, Inc.
2017-11-06

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