Ventix Suture Anchor

Fastener, Fixation, Nondegradable, Soft Tissue

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Ventix Suture Anchor.

Pre-market Notification Details

Device IDK153558
510k NumberK153558
Device Name:Ventix Suture Anchor
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw,  IN  46581
ContactAdam Cargill
CorrespondentAdam Cargill
BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw,  IN  46581
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-14
Decision Date2016-04-21
Summary:summary

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