Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K223146
EVOLUTION SPINE Interbody System · Evolution Spine · decided 2023-02-07 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| E3D-A Interbody System | 111G-L2518 | Evolution Spine LLC | MAX PHM | 10195860022198 |
| E3D-A Interbody System | 111G-S2520 | Evolution Spine LLC | MAX PHM | 10195860021016 |
| E3D-A Interbody System | 110G-ML0813 | Evolution Spine LLC | MAX OVD PHM | 10195860017224 |
| E3D-A Interbody System | 110G-M2517 | Evolution Spine LLC | MAX OVD PHM | 10195860017125 |
| E3D-A Interbody System | 110G-ML2019 | Evolution Spine LLC | MAX OVD PHM | 10195860017460 |
| E3D-A Interbody System | 111G-M0817 | Evolution Spine LLC | MAX PHM | 10195860021146 |
| E3D-A Interbody System | 111G-S3018 | Evolution Spine LLC | MAX PHM | 10195860021030 |
| E3D-A Interbody System | 111G-L1515 | Evolution Spine LLC | MAX PHM | 10195860022020 |
| E3D-A Interbody System | 111G-M1514 | Evolution Spine LLC | MAX PHM | 10195860021214 |
| E3D-A Interbody System | 111G-M0810 | Evolution Spine LLC | MAX PHM | 10195860021078 |
| E3D-A Interbody System | 110G-L2014 | Evolution Spine LLC | MAX OVD PHM | 10195860017798 |
| E3D-A Interbody System | 110G-M2016 | Evolution Spine LLC | MAX OVD PHM | 10195860017057 |
| E3D-A Interbody System | 111G-M2021 | Evolution Spine LLC | MAX PHM | 10195860022440 |
| E3D-A Interbody System | 111G-ML2520 | Evolution Spine LLC | MAX PHM | 10195860021818 |
| E3D-A Interbody System | 110G-S0817 | Evolution Spine LLC | MAX OVD PHM | 10195860016500 |
| E3D-A Interbody System | 111G-M2516 | Evolution Spine LLC | MAX PHM | 10195860021375 |
| E3D-A Interbody System | 111G-M1518 | Evolution Spine LLC | MAX PHM | 10195860021252 |
| E3D-A Interbody System | 111G-M1516 | Evolution Spine LLC | MAX PHM | 10195860021238 |
| E3D-A Interbody System | 110G-M0817 | Evolution Spine LLC | MAX OVD PHM | 10195860016883 |
| E3D-A Interbody System | 110G-L2521 | Evolution Spine LLC | MAX OVD PHM | 10195860022754 |
| E3D-A Interbody System | 111G-S0815 | Evolution Spine LLC | MAX PHM | 10195860020729 |
| E3D-A Interbody System | 110G-M0820 | Evolution Spine LLC | MAX OVD PHM | 10195860016913 |
| E3D-A Interbody System | 111G-ML3021 | Evolution Spine LLC | MAX PHM | 10195860022518 |
| E3D-A Interbody System | 111G-L0811 | Evolution Spine LLC | MAX PHM | 10195860021887 |
| E3D-A Interbody System | 111G-S1514 | Evolution Spine LLC | MAX PHM | 10195860020811 |