CoLink Cfx 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 Cfx Plating System.

Pre-market Notification Details

Device IDK200762
510k NumberK200762
Device Name:CoLink Cfx 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 Received2020-03-24
Decision Date2020-04-23

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