Hercules Syndesmosis Implant System

Washer, Bolt Nut

In2Bones USA, LLC

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

Pre-market Notification Details

Device IDK220260
510k NumberK220260
Device Name:Hercules Syndesmosis Implant System
ClassificationWasher, Bolt Nut
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 CodeHTN  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-31
Decision Date2022-03-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00810021861470 K220260 000

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