FDA 510(k) Applications Submitted by Byron Ledbetter
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K150133 |
01/21/2015 |
PROFEMUR Preserve Size 1-3 Hip Stems |
MICROPORT ORTHOPEDICS, INC. |
| K140676 |
03/18/2014 |
PROFEMUR TL CLASSIC LONG NECK HIP STEMS |
MICROPORT ORTHOPEDICS INC. |
| K141235 |
05/13/2014 |
PROFEMUR RENAISSANCE CLASSIC LONG NECK 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. |
| K142119 |
08/04/2014 |
PROCOTYL L-O ACETABULAR SYSTEM |
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. |
| K182251 |
08/20/2018 |
EVOLUTION NitrX Medial-Pivot Knee |
MircoPort Orthopedics, Inc. |
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