CoLink Plating System, Fracture And Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx 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 Plating System, Fracture And Correction System, Colink Mini Plating System, Colink View Plating System, Colink Afx Plating System.

Pre-market Notification Details

Device IDK193543
510k NumberK193543
Device Name:CoLink Plating System, Fracture And Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx 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)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-20
Decision Date2020-01-17

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