Cannulated Hemi Implant

Prosthesis, Toe, Hemi-, Phalangeal

Vilex In Tennessee, Inc.

The following data is part of a premarket notification filed by Vilex In Tennessee, Inc. with the FDA for Cannulated Hemi Implant.

Pre-market Notification Details

Device IDK190543
510k NumberK190543
Device Name:Cannulated Hemi Implant
ClassificationProsthesis, Toe, Hemi-, Phalangeal
Applicant Vilex In Tennessee, Inc. 111 Moffitt Street Mcminnville,  TN  37110
ContactSylvia Southard
CorrespondentVictor Lavi
Vilex In Tennessee, Inc. 111 Moffitt Street Mcminnville,  TN  37110
Product CodeKWD  
CFR Regulation Number888.3730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-04
Decision Date2019-05-31

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