ExpressBraid Graft Manipulation

Suture, Nonabsorbable, Synthetic, Polyethylene

Biomet Manufacturing Corp.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Expressbraid Graft Manipulation.

Pre-market Notification Details

Device IDK163651
510k NumberK163651
Device Name:ExpressBraid Graft Manipulation
ClassificationSuture, Nonabsorbable, Synthetic, Polyethylene
Applicant Biomet Manufacturing Corp. 56 East Bell Drive PO Box 587 Warsaw,  IN  46581
ContactVinay Bhal
CorrespondentVinay Bhal
Biomet Manufacturing Corp. 56 East Bell Drive PO Box 587 Warsaw,  IN  46581
Product CodeGAT  
CFR Regulation Number878.5000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-23
Decision Date2017-02-17
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.