MODULAR PROTUSIO CUP

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Modular Protusio Cup.

Pre-market Notification Details

Device IDK990032
510k NumberK990032
Device Name:MODULAR PROTUSIO CUP
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw,  IN  46581 -0587
ContactDalene Hufziger Binkley
CorrespondentDalene Hufziger Binkley
BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw,  IN  46581 -0587
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-01-06
Decision Date1999-02-18
Summary:summary

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