CoLink View 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 View Plating System.

Pre-market Notification Details

Device IDK182402
510k NumberK182402
Device Name:CoLink View Plating System
ClassificationPlate, Fixation, Bone
Applicant In2Bones USA, LLC 6060 Poplar Ave, Suite 380 Memphis,  TN  38119
ContactChristine Scifert
CorrespondentChristine Scifert
In2Bones USA, LLC 6060 Poplar Ave, Suite 380 Memphis,  TN  38119
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-04
Decision Date2018-09-27

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