Ligament Staple

Staple, Fixation, Bone

Medacta International SA

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

Pre-market Notification Details

Device IDK210456
510k NumberK210456
Device Name:Ligament Staple
ClassificationStaple, Fixation, Bone
Applicant Medacta International SA Strada Regina Castel San Pietro,  CH Ch-6874
ContactStefano Baj
CorrespondentChris Lussier
Medacta USA 3973 Delp Street Memphis,  TN  83118
Product CodeJDR  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-16
Decision Date2021-04-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630971258594 K210456 000
07630345719133 K210456 000

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