MectaLock All-Suture Anchors

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 Mectalock All-suture Anchors.

Pre-market Notification Details

Device IDK193461
510k NumberK193461
Device Name:MectaLock All-Suture Anchors
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)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-16
Decision Date2020-02-06


Device IdentifiersubmissionNumberSupplement
07630971259140 K193461 000
07630971259133 K193461 000
07630971259126 K193461 000
07630971259119 K193461 000
07630971259102 K193461 000
07630971259096 K193461 000

© 2020
This site is not affiliated with or endorsed by the FDA.