HEALIX Ti Dual Threaded Suture Anchor With DYNATAPE Suture

Fastener, Fixation, Nondegradable, Soft Tissue

Medos International Sarl

The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Healix Ti Dual Threaded Suture Anchor With Dynatape Suture.

Pre-market Notification Details

Device IDK203794
510k NumberK203794
Device Name:HEALIX Ti Dual Threaded Suture Anchor With DYNATAPE Suture
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Medos International Sarl Chemin-Blanc 38, Case Postale Le Locle,  CH Ch 2400
ContactElizabeth Messana
CorrespondentElizabeth Messana
Depuy Synthes Mitek, A Johnson & Johnson Company 325 Paramount Drive Raynham,  MA  02767
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-28
Decision Date2021-02-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886705031177 K203794 000
10886705031160 K203794 000
10886705031153 K203794 000
10886705031146 K203794 000
10886705031139 K203794 000
10886705031122 K203794 000

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