3DMetal Tibial Cones

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

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for 3dmetal Tibial Cones.

Pre-market Notification Details

Device IDK170149
510k NumberK170149
Device Name:3DMetal Tibial Cones
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Medacta International SA Strada Regina Castel San Pietro,  CH Ch-6874
ContactStefano Baj
CorrespondentElizabeth Rose
Mapi USA, Inc 2343 Alexandria Drive Suite 100 Lexington,  KY  40504
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-17
Decision Date2017-08-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630030884146 K170149 000
07630030884061 K170149 000
07630030884078 K170149 000
07630030884085 K170149 000
07630030884092 K170149 000
07630030884108 K170149 000
07630030884115 K170149 000
07630030884122 K170149 000
07630030884139 K170149 000
07630030884054 K170149 000

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