Porous Patella And Porous Tibia Baseplate

Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

Smith & Nephew, Inc.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Porous Patella And Porous Tibia Baseplate.

Pre-market Notification Details

Device IDK211221
510k NumberK211221
Device Name:Porous Patella And Porous Tibia Baseplate
ClassificationProsthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Applicant Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova,  TN  38016
ContactBrad Sheals
CorrespondentBrad Sheals
Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova,  TN  38016
Product CodeMBH  
CFR Regulation Number888.3565 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-23
Decision Date2021-10-01

NIH GUDID Devices

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