Vario-Cup System

Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or 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 Vario-cup System.

Pre-market Notification Details

Device IDK221794
510k NumberK221794
Device Name:Vario-Cup System
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Applicant Waldemar Link GmbH & Co. KG Oststraße 4-10 Norderstedt,  DE 22844
ContactPia Mueller
CorrespondentMateusz Leszczak
LinkBio Corp. 69 King Street Dover,  NJ  07801
Product CodeKWY  
CFR Regulation Number888.3390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-21
Decision Date2022-07-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04026575395910 K221794 000
04026575352791 K221794 000
04026575352784 K221794 000
04026575352777 K221794 000
04026575352760 K221794 000
04026575352753 K221794 000

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