MectaScrew PEEK Interference Screw

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 Mectascrew Peek Interference Screw.

Pre-market Notification Details

Device IDK190892
510k NumberK190892
Device Name:MectaScrew PEEK Interference Screw
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 Received2019-04-05
Decision Date2019-06-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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07630040723541 K190892 000
07630040723374 K190892 000

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