ICONN Answer II Suture Anchor

Fastener, Fixation, Nondegradable, Soft Tissue

ICONN Orthopedics, LLC

The following data is part of a premarket notification filed by Iconn Orthopedics, Llc with the FDA for Iconn Answer Ii Suture Anchor.

Pre-market Notification Details

Device IDK181680
510k NumberK181680
Device Name:ICONN Answer II Suture Anchor
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant ICONN Orthopedics, LLC 400 Union Hill Drive, Suite 150 Birmingham,  AL  35209
ContactWhitt Israel
CorrespondentWhitt Israel
ICONN Orthopedics, LLC 400 Union Hill Drive, Suite 150 Birmingham,  AL  35209
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-26
Decision Date2018-08-09
Summary:summary

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