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 IDK152868
510k NumberK152868
Device Name:ExpressBraid Graft Manipulation
ClassificationSuture, Nonabsorbable, Synthetic, Polyethylene
Applicant BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw,  IL  46581
ContactAdam Cargill
CorrespondentAdam Cargill
BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw,  IL  46581
Product CodeGAT  
CFR Regulation Number878.5000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-30
Decision Date2016-02-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304566712 K152868 000
00880304566705 K152868 000
00880304566675 K152868 000
00880304566668 K152868 000
70887868462565 K152868 000
00887868462689 K152868 000
00887868462672 K152868 000
70887868462558 K152868 000

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