HEALICOIL Knotless Suture Anchors

Fastener, Fixation, Biodegradable, Soft Tissue

Smith & Nephew, Inc.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Healicoil Knotless Suture Anchors.

Pre-market Notification Details

Device IDK193558
510k NumberK193558
Device Name:HEALICOIL Knotless Suture Anchors
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova,  TN  38016
ContactCamille Black
CorrespondentCamille Black
Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova,  TN  38016
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-23
Decision Date2020-03-18

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