SnugFit All-Suture Anchor

Fastener, Fixation, Nondegradable, Soft Tissue

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Snugfit All-suture Anchor.

Pre-market Notification Details

Device IDK203485
510k NumberK203485
Device Name:SnugFit All-Suture Anchor
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Medacta International SA Strada Regina Castel San Pietro,  CH Ch-6874
ContactStefano Baj
CorrespondentChris Lussier
Medacta USA 3973 Delp Street Memphis,  TN  38118
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-27
Decision Date2021-01-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630345717184 K203485 000
07630345714060 K203485 000
07630345712769 K203485 000
07630345712752 K203485 000
07630345712745 K203485 000
07630345712738 K203485 000

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