MotoCLIP/HiMAX Implant System

Staple, 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 Motoclip/himax Implant System.

Pre-market Notification Details

Device IDK181410
510k NumberK181410
Device Name:MotoCLIP/HiMAX Implant System
ClassificationStaple, Fixation, Bone
Applicant CrossRoads Extremity Systems, LLC 6055 Primacy Parkway, Suite 140 Memphis,  TN  38119
ContactChad Hollis
CorrespondentChristine Seifert
MRC-X,LLC 6075 Poplar Ave Memphis,  TN  38119
Product CodeJDR  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-30
Decision Date2018-06-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00810112597622 K181410 000
00810112597592 K181410 000
00810112597585 K181410 000

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