BiMobile Instruments (for BiMobile Dual Mobility System)

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

Waldemar Link GmbH & Co. KG

The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Bimobile Instruments (for Bimobile Dual Mobility System).

Pre-market Notification Details

Device IDK211567
510k NumberK211567
Device Name:BiMobile Instruments (for BiMobile Dual Mobility System)
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant Waldemar Link GmbH & Co. KG Oststraße 4-10 Norderstedt,  DE 22844
ContactStefanie Fuchs
CorrespondentStefani Fuchs
LinkBio Corp. Oststraße 4-10 Nordertedt,  DE 22844
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-21
Decision Date2022-06-03

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