MectaTap TI 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 Mectatap Ti Suture Anchor.

Pre-market Notification Details

Device IDK191677
510k NumberK191677
Device Name:MectaTap TI 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 Received2019-06-24
Decision Date2020-01-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630040734233 K191677 000
07630040734226 K191677 000

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