BIOMET CABLE SYSTEM

Cerclage, Fixation

BIOMET MANUFACTURING, INC.

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

Pre-market Notification Details

Device IDK071271
510k NumberK071271
Device Name:BIOMET CABLE SYSTEM
ClassificationCerclage, Fixation
Applicant BIOMET MANUFACTURING, INC. P.O. BOX 587 Warsaw,  IN  46581 -0578
ContactBecky Earl
CorrespondentBecky Earl
BIOMET MANUFACTURING, INC. P.O. BOX 587 Warsaw,  IN  46581 -0578
Product CodeJDQ  
CFR Regulation Number888.3010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-05-07
Decision Date2007-10-23
Summary:summary

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