Hercules Suture Anchor System

Fastener, Fixation, Nondegradable, Soft Tissue

In2Bones USA, LLC

The following data is part of a premarket notification filed by In2bones Usa, Llc with the FDA for Hercules Suture Anchor System.

Pre-market Notification Details

Device IDK201636
510k NumberK201636
Device Name:Hercules Suture Anchor System
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
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 CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-16
Decision Date2020-08-20

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