CUSTOM FLANGED ACETABULAR COMPONENT

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Custom Flanged Acetabular Component.

Pre-market Notification Details

Device IDK983035
510k NumberK983035
Device Name:CUSTOM FLANGED ACETABULAR COMPONENT
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant BIOMET, INC. P.O. BOX 587 Warsaw,  IN  46581 -0587
ContactPatricia Sandborn Beres
CorrespondentPatricia Sandborn Beres
BIOMET, INC. P.O. BOX 587 Warsaw,  IN  46581 -0587
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-08-31
Decision Date1998-11-23
Summary:summary

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