MPO Knee Instruments; MPO PROPHECY Knee Instruments

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 Mpo Knee Instruments; Mpo Prophecy Knee Instruments.

Pre-market Notification Details

Device IDK213817
510k NumberK213817
Device Name:MPO Knee Instruments; MPO PROPHECY Knee Instruments
ClassificationProsthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Applicant MicroPort Orthopedics Inc. 5677 Airline Road Arlington,  TN  38002
ContactGillen Gonzales
CorrespondentGillen Gonzales
MicroPort Orthopedics Inc. 5677 Airline Road Arlington,  TN  38002
Product CodeMBH  
Subsequent Product CodeJWH
Subsequent Product CodeOOG
CFR Regulation Number888.3565 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-07
Decision Date2022-01-05

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