CrossTie Intraosseous Fixation System

Screw, Fixation, Bone

ORTHODISCOVERY GROUP LLC (D.B.A. CROSSROADS EXTREM

The following data is part of a premarket notification filed by Orthodiscovery Group Llc (d.b.a. Crossroads Extrem with the FDA for Crosstie Intraosseous Fixation System.

Pre-market Notification Details

Device IDK141857
510k NumberK141857
Device Name:CrossTie Intraosseous Fixation System
ClassificationScrew, Fixation, Bone
Applicant ORTHODISCOVERY GROUP LLC (D.B.A. CROSSROADS EXTREM 458 DISTRIBUTION PKWY Collierville,  TN  38017
ContactVernon Hartdegen
CorrespondentVernon Hartdegen
ORTHODISCOVERY GROUP LLC (D.B.A. CROSSROADS EXTREM 458 DISTRIBUTION PKWY Collierville,  TN  38017
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-10
Decision Date2015-01-08
Summary:summary

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