FDA 510(k) Applications Submitted by MicroPort Orthopedics, Inc.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K150133 |
01/21/2015 |
PROFEMUR Preserve Size 1-3 Hip Stems |
MICROPORT ORTHOPEDICS, INC. |
K162026 |
07/22/2016 |
EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions |
MicroPort Orthopedics, Inc. |
K152298 |
08/13/2015 |
EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base |
MICROPORT ORTHOPEDICS, INC. |
K170288 |
01/30/2017 |
BIOFOAM« Additive Manufacturing (BIOFOAM« AM), ADVANCE« BIOFOAM« Tibial Base, EVOLUTION« BIOFOAM« Tibial Base, DYNASTY« BIOFOAM« Acetabular Shell |
MicroPort Orthopedics, Inc. |
K180317 |
02/05/2018 |
EVOLUTION« Knee Systems û MR Labeling, EVOLUTION« BIOFOAM« Tibial System, EVOLUTION« Revision Tibial System, EVOLUTION« Revision CCK System |
MicroPort Orthopedics, Inc. |
K200011 |
01/02/2020 |
E-CLASS« DUAL MOBILITY INSERTS and DYNASTY« DUAL MOBILITY LINERS |
Microport Orthopedics, Inc. |
K171181 |
04/24/2017 |
PROCOTYL« PRIME E-CLASSÖ XLPE Liner |
MicroPort Orthopedics, Inc. |
K152631 |
09/15/2015 |
MPO Total Knee Systems MR Labeling |
MICROPORT ORTHOPEDICS, INC. |
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