CoLink PCR 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 Pcr Plating System.

Pre-market Notification Details

Device IDK213698
510k NumberK213698
Device Name:CoLink PCR 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 Received2021-11-23
Decision Date2022-05-27

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