EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base

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

MICROPORT ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Microport Orthopedics, Inc. with the FDA for Evolution Biofoam Tibial Base, Evolution Modular Keels, Advance Modular Keels, Advance Bullet-tipped Keels, Advance Biofoam Tibial Base.

Pre-market Notification Details

Device IDK152298
510k NumberK152298
Device Name:EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base
ClassificationProsthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Applicant MICROPORT ORTHOPEDICS, INC. 5677 AIRLINE ROAD Arlington,  TN  38002
ContactByron Ledbetter
CorrespondentByron Ledbetter
MICROPORT ORTHOPEDICS, INC. 5677 AIRLINE ROAD Arlington,  TN  38002
Product CodeMBH  
CFR Regulation Number888.3565 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-13
Decision Date2015-11-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M684ETPSB2PR1 K152298 000

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