MAESTRO CARPAL HEMIARTHROPLASTY

Prosthesis, Wrist, Carpal Lunate

BIOMET MANUFACTURING, INC.

The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Maestro Carpal Hemiarthroplasty.

Pre-market Notification Details

Device IDK050028
510k NumberK050028
Device Name:MAESTRO CARPAL HEMIARTHROPLASTY
ClassificationProsthesis, Wrist, Carpal Lunate
Applicant BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw,  IN  46581 -0587
ContactPatricia Sandborn Beres
CorrespondentPatricia Sandborn Beres
BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw,  IN  46581 -0587
Product CodeKWN  
CFR Regulation Number888.3750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-01-06
Decision Date2005-03-25
Summary:summary

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