InCore TMT System

Screw, Fixation, Bone

Nextremity Solutions, Inc.

The following data is part of a premarket notification filed by Nextremity Solutions, Inc. with the FDA for Incore Tmt System.

Pre-market Notification Details

Device IDK192578
510k NumberK192578
Device Name:InCore TMT System
ClassificationScrew, Fixation, Bone
Applicant Nextremity Solutions, Inc. 210 North Buffalo Street Warsaw,  IN  46580
ContactElise Fox
CorrespondentElise Fox
Nextremity Solutions, Inc. 210 North Buffalo Street Warsaw,  IN  46580
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-19
Decision Date2019-12-31
Summary:summary

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