MyKnee R Pin Positioners

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

Medacta International S.A.

The following data is part of a premarket notification filed by Medacta International S.a. with the FDA for Myknee R Pin Positioners.

Pre-market Notification Details

Device IDK220705
510k NumberK220705
Device Name:MyKnee R Pin Positioners
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Medacta International S.A. Strada Regina Castel San Pietro,  CH Ch-6874
ContactStefano Baj
CorrespondentChris Lussier
Medacta USA 3973 Delp Street Memphis,  TN  38118
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-10
Decision Date2022-05-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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