FootHold System

Fastener, Fixation, Nondegradable, Soft Tissue

CrossRoads Extremity Systems, LLC

The following data is part of a premarket notification filed by Crossroads Extremity Systems, Llc with the FDA for Foothold System.

Pre-market Notification Details

Device IDK220797
510k NumberK220797
Device Name:FootHold System
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant CrossRoads Extremity Systems, LLC 6423 Shelby View Dr., Suite 101 Memphis,  TN  38134
ContactKim Strohkirch
CorrespondentKim Strohkirch
CrossRoads Extremity Systems, LLC 6423 Shelby View Dr., Suite 101 Memphis,  TN  38134
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-18
Decision Date2022-04-15

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.