Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K182987
Genesys Spine 3DP Lumbar Interbody System · Genesys Spine · decided 2019-12-12 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| 3DP Lumbar Interbody System | 1 | Genesys Orthopedics Systems LLC | MAX | M719GT3D12SL0 |
| 3DP Lumbar Interbody System | 1 | Genesys Orthopedics Systems LLC | MAX | M719GP3D0830L80 |
| 3DP Lumbar Interbody System | 1 | Genesys Orthopedics Systems LLC | MAX | M719GP1216TI0 |
| 3DP Lumbar Interbody System | 1 | Genesys Orthopedics Systems LLC | MAX | M719GA3D1606L0 |
| 3DP Lumbar Interbody System | 1 | Genesys Orthopedics Systems LLC | HTX | M719GP53160 |
| 3DP Lumbar Interbody System | 1 | Genesys Orthopedics Systems LLC | MAX | M719GP526080 |
| 3DP Lumbar Interbody System | 1 | Genesys Orthopedics Systems LLC | MAX | M719GP3D1328L40 |
| 3DP Lumbar Interbody System | 1 | Genesys Orthopedics Systems LLC | MAX | M719GP3D1232L80 |
| 3DP Lumbar Interbody System | 1 | Genesys Orthopedics Systems LLC | MAX | M719GP1220LS0 |
| 3DP Lumbar Interbody System | 1 | Genesys Orthopedics Systems LLC | MAX | M719GL3DM1830P0 |
| 3DP Lumbar Interbody System | 1 | Genesys Orthopedics Systems LLC | MAX | M719GL3DM1430080 |
| 3DP Lumbar Interbody System | 1 | Genesys Orthopedics Systems LLC | MAX | M719GPH418M0 |
| 3DP Lumbar Interbody System | 1 | Genesys Orthopedics Systems LLC | MAX | M719GPH1824S0 |
| 3DP Lumbar Interbody System | 1 | Genesys Orthopedics Systems LLC | HTF | M719GP5330 |
| 3DP Lumbar Interbody System | 1 | Genesys Orthopedics Systems LLC | MAX | M719GP2418LS0 |
| 3DP Lumbar Interbody System | 1 | Genesys Orthopedics Systems LLC | MAX | M719GL3DS1640P0 |
| 3DP Lumbar Interbody System | 1 | Genesys Orthopedics Systems LLC | MAX | M719GL3DS1630080 |
| 3DP Lumbar Interbody System | 1 | Genesys Orthopedics Systems LLC | MAX | M719GL3DS1435P0 |
| 3DP Lumbar Interbody System | 1 | Genesys Orthopedics Systems LLC | MAX | M719GP1212TI0 |
| 3DP Lumbar Interbody System | 1 | Genesys Orthopedics Systems LLC | MAX | M719GLL1010 |
| 3DP Lumbar Interbody System | 1 | Genesys Orthopedics Systems LLC | MAX | M719GL3DS1835P0 |
| 3DP Lumbar Interbody System | 1 | Genesys Orthopedics Systems LLC | MAX | M719GL3DS1655080 |
| 3DP Lumbar Interbody System | 1 | Genesys Orthopedics Systems LLC | MAX | M719GL3DS1460P0 |
| 3DP Lumbar Interbody System | 1 | Genesys Orthopedics Systems LLC | MAX | M719GL3DM1845150 |
| 3DP Lumbar Interbody System | 1 | Genesys Orthopedics Systems LLC | MAX | M719GL3DM1655150 |