MAESTRO TOTAL WRIST

Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained

BIOMET, INC.

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

Pre-market Notification Details

Device IDK042032
510k NumberK042032
Device Name:MAESTRO TOTAL WRIST
ClassificationProsthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained
Applicant BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw,  IN  46581 -0587
ContactPatricia Sandborn Beres
CorrespondentPatricia Sandborn Beres
BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw,  IN  46581 -0587
Product CodeJWJ  
CFR Regulation Number888.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-07-28
Decision Date2004-10-07
Summary:summary

NIH GUDID Devices

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