VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)

Staple, Fixation, Bone

VILEX, INC.

The following data is part of a premarket notification filed by Vilex, Inc. with the FDA for Vilex Ez-staple (memory Bone Fixation Staple).

Pre-market Notification Details

Device IDK112837
510k NumberK112837
Device Name:VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)
ClassificationStaple, Fixation, Bone
Applicant VILEX, INC. 111 MOFFITT STREET Mcminnville,  TN  37110
ContactSylvia Southard
CorrespondentSylvia Southard
VILEX, INC. 111 MOFFITT STREET Mcminnville,  TN  37110
Product CodeJDR  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-28
Decision Date2012-10-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00841731106650 K112837 000

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