The Optimotion Blue Total Knee System

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

Optimotion Implants, LLC

The following data is part of a premarket notification filed by Optimotion Implants, Llc with the FDA for The Optimotion Blue Total Knee System.

Pre-market Notification Details

Device IDK191084
510k NumberK191084
Device Name:The Optimotion Blue Total Knee System
ClassificationProsthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Applicant Optimotion Implants, LLC 5931 Brick Court, Suite 130 Winter Park,  FL  32792
ContactDan Justin
CorrespondentRobert A Poggie
BioVera, Inc. 65 Promenade Saint Louis Notre Dame De Lile Perrot,  CA J7v 7p2
Product CodeMBH  
Subsequent Product CodeJWH
Subsequent Product CodeOIY
CFR Regulation Number888.3565 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-24
Decision Date2020-04-07

NIH GUDID Devices

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