MectaLock Extension

Fastener, Fixation, Biodegradable, Soft Tissue

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Mectalock Extension.

Pre-market Notification Details

Device IDK203493
510k NumberK203493
Device Name:MectaLock Extension
ClassificationFastener, Fixation, Biodegradable, 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 CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-27
Decision Date2021-02-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630345701466 K203493 000
07630345701459 K203493 000
07630345701442 K203493 000

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