Rotium Bioresorbable Wick

Fastener, Fixation, Biodegradable, Soft Tissue

Nanofiber Solutions, LLC

The following data is part of a premarket notification filed by Nanofiber Solutions, Llc with the FDA for Rotium Bioresorbable Wick.

Pre-market Notification Details

Device IDK201414
510k NumberK201414
Device Name:Rotium Bioresorbable Wick
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant Nanofiber Solutions, LLC 4389 Weaver Ct. N. Hilliard,  OH  43026
ContactJason Chakroff
CorrespondentJason Chakroff
Nanofiber Solutions, LLC 4389 Weaver Ct. N. Hilliard,  OH  43026
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-29
Decision Date2020-06-25

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