FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL

Rod, Fixation, Intramedullary And Accessories

VILEX, INC.

The following data is part of a premarket notification filed by Vilex, Inc. with the FDA for Fuze: Intramedullary Internal Fixation Nail.

Pre-market Notification Details

Device IDK102413
510k NumberK102413
Device Name:FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant VILEX, INC. 111 MOFFITT STREET Mcminnville,  TN  37110
ContactAbe Lavi
CorrespondentAbe Lavi
VILEX, INC. 111 MOFFITT STREET Mcminnville,  TN  37110
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-24
Decision Date2011-11-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841731107091 K102413 000
00841731107220 K102413 000
00841731107237 K102413 000
00841731107244 K102413 000
00841731107251 K102413 000
00841731107268 K102413 000
00841731107275 K102413 000
00841731107299 K102413 000
00841731107305 K102413 000
00841731114617 K102413 000
00841731107213 K102413 000
00841731107206 K102413 000
00841731107107 K102413 000
00841731107114 K102413 000
00841731107121 K102413 000
00841731107145 K102413 000
00841731107152 K102413 000
00841731107169 K102413 000
00841731107176 K102413 000
00841731107183 K102413 000
00841731107190 K102413 000
00841731115096 K102413 000
00841731115386 K102413 000
00841731115652 K102413 000
00841731120427 K102413 000
00841731120434 K102413 000
00841731120458 K102413 000
00841731120595 K102413 000
00841731120601 K102413 000
00841731120618 K102413 000
00841731120625 K102413 000
00841731120632 K102413 000
00841731120649 K102413 000
00841731120410 K102413 000
00841731120403 K102413 000
00841731115669 K102413 000
00841731115676 K102413 000
00841731115683 K102413 000
00841731119988 K102413 000
00841731119995 K102413 000
00841731120229 K102413 000
00841731120267 K102413 000
00841731120380 K102413 000
00841731120397 K102413 000
00841731120717 K102413 000

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