Gexfix External Fixation

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

Gexfix International Corp.

The following data is part of a premarket notification filed by Gexfix International Corp. with the FDA for Gexfix External Fixation.

Pre-market Notification Details

Device IDK160972
510k NumberK160972
Device Name:Gexfix External Fixation
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant Gexfix International Corp. 55 NE Avenue, Suite 501 Boca Raton,  FL  33432
ContactMaurizio Longo
CorrespondentRoger Gray
DONAWA LIFESCIENCE CONSULTING S.R.L. PIAZZA ALBANIA, 10 Rome,  IT 00153
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-06
Decision Date2016-12-28
Summary:summary

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