MIS Bunion System

Plate, Fixation, Bone

CrossRoads Extremity Systems, LLC

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

Pre-market Notification Details

Device IDK181872
510k NumberK181872
Device Name:MIS Bunion System
ClassificationPlate, Fixation, Bone
Applicant CrossRoads Extremity Systems, LLC 6055 Primacy Parkway, Suite 140 Memphis,  TN  38119
ContactChad Hollis
CorrespondentTheresa Leister
MRC-X, LLC 6075 Poplar Ave Memphis,  TN  38119
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-12
Decision Date2019-02-19
Summary:summary

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