CoLink Vallux Plating System

Plate, Fixation, Bone

In2Bones USA, LLC

The following data is part of a premarket notification filed by In2bones Usa, Llc with the FDA for Colink Vallux Plating System.

Pre-market Notification Details

Device IDK212487
510k NumberK212487
Device Name:CoLink Vallux Plating System
ClassificationPlate, Fixation, Bone
Applicant In2Bones USA, LLC 6000 Poplar Ave, Suite 115 Memphis,  TN  38119
ContactChristine Scifert
CorrespondentChristine Scifert
In2Bones USA, LLC 6000 Poplar Ave, Suite 115 Memphis,  TN  38119
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-09
Decision Date2021-11-18

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.