LINK CEMENTLESS SCREW-IN ACETABULAR CUP

Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)

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 Link Cementless Screw-in Acetabular Cup.

Pre-market Notification Details

Device IDK843940
510k NumberK843940
Device Name:LINK CEMENTLESS SCREW-IN ACETABULAR CUP
ClassificationProsthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Applicant WALDEMAR LINK GMBH & CO. KG 10 GREAT MEADOW LN. E. Hanover,  NJ  07936
ContactEd Schussler
CorrespondentEd Schussler
WALDEMAR LINK GMBH & CO. KG 10 GREAT MEADOW LN. E. Hanover,  NJ  07936
Product CodeKWA  
CFR Regulation Number888.3330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-10-09
Decision Date1985-06-03

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