TRIDENT FUSION IMPLANT

Screw, Fixation, Bone

VILEX IN TENNESSEE, INC.

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

Pre-market Notification Details

Device IDK141937
510k NumberK141937
Device Name:TRIDENT FUSION IMPLANT
ClassificationScrew, Fixation, Bone
Applicant VILEX IN TENNESSEE, INC. 8374 MARKET STREET, #167 Lakewood Ranch,  FL  34202
ContactAbraham Lavi
CorrespondentAbraham Lavi
VILEX IN TENNESSEE, INC. 8374 MARKET STREET, #167 Lakewood Ranch,  FL  34202
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-17
Decision Date2014-09-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841731114716 K141937 000
00841731106889 K141937 000
00841731106872 K141937 000
00841731106865 K141937 000
00841731106858 K141937 000
00841731106841 K141937 000
00841731106834 K141937 000

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