CoLink Mfx Implant 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 Mfx Implant System.

Pre-market Notification Details

Device IDK210060
510k NumberK210060
Device Name:CoLink Mfx Implant 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 Received2021-01-11
Decision Date2021-03-12

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