BIOMET'S MINIMALLY CONSTRAINED ELBOW

Prosthesis, Elbow, Constrained, Cemented

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Biomet's Minimally Constrained Elbow.

Pre-market Notification Details

Device IDK003253
510k NumberK003253
Device Name:BIOMET'S MINIMALLY CONSTRAINED ELBOW
ClassificationProsthesis, Elbow, Constrained, Cemented
Applicant BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw,  IN  46581 -0587
ContactSara A Bailey
CorrespondentSara A Bailey
BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw,  IN  46581 -0587
Product CodeJDC  
CFR Regulation Number888.3150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-10-17
Decision Date2001-01-12

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