Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K191489
Genesys Spine 3DP Cervical Interbody System · Genesys Spine · decided 2020-01-08 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| 3DP Cervical Interbody System | 1 | Genesys Orthopedics Systems LLC | ODP OVE | M719GC3THS120 |
| 3DP Cervical Interbody System | 1 | Genesys Orthopedics Systems LLC | ODP OVE | M719GC3RHL110 |
| 3DP Cervical Interbody System | 1 | Genesys Orthopedics Systems LLC | ODP OVE | M719GC3THSS060 |
| 3DP Cervical Interbody System | 1 | Genesys Orthopedics Systems LLC | ODP OVE | M719GC3RHS110 |
| 3DP Cervical Interbody System | 1 | Genesys Orthopedics Systems LLC | ODP OVE | M719GC3TS090 |
| 3DP Cervical Interbody System | 1 | Genesys Orthopedics Systems LLC | ODP OVE | M719GAC3D07LL0 |
| 3DP AIS-C II Cervical Interbody System | 1 | Genesys Orthopedics Systems LLC | ODP OVE | M719ACC80410L0 |
| 3DP Cervical Interbody System | 1 | Genesys Orthopedics Systems LLC | ODP OVE | M719GC3RHS050 |
| 3DP Cervical Interbody System | 1 | Genesys Orthopedics Systems LLC | ODP OVE | M719GCC3D12L0 |
| 3DP Cervical Interbody System | 1 | Genesys Orthopedics Systems LLC | ODP OVE | M719GCP3D05L0 |
| 3DP Cervical Interbody System | 1 | Genesys Orthopedics Systems LLC | ODP OVE | M719GC3THS110 |
| 3DP Cervical Interbody System | 1 | Genesys Orthopedics Systems LLC | ODP OVE | M719GC3THSS080 |
| 3DP Cervical Interbody System | 1 | Genesys Orthopedics Systems LLC | ODP OVE | M719GC3THS070 |
| 3DP Cervical Interbody System | 1 | Genesys Orthopedics Systems LLC | ODP OVE | M719GCL3D09S0 |
| 3DP Cervical Interbody System | 1 | Genesys Orthopedics Systems LLC | ODP OVE | M719GAC3D12LL0 |
| 3DP Cervical Interbody System | 1 | Genesys Orthopedics Systems LLC | ODP OVE | M719GC3THSS070 |
| 3DP Cervical Interbody System | 1 | Genesys Orthopedics Systems LLC | ODP OVE | M719GC3THL09SD0 |
| 3DP Cervical Interbody System | 1 | Genesys Orthopedics Systems LLC | ODP OVE | M719GCP3D10L0 |
| 3DP Cervical Interbody System | 1 | Genesys Orthopedics Systems LLC | ODP OVE | M719GCP3D07S0 |
| 3DP Cervical Interbody System | 1 | Genesys Orthopedics Systems LLC | ODP OVE | M719GC3RHL120 |
| 3DP AIS-C II Cervical Interbody System | 1 | Genesys Orthopedics Systems LLC | ODP OVE | M719ACC80405L0 |
| 3DP Cervical Interbody System | 1 | Genesys Orthopedics Systems LLC | ODP OVE | M719GC3THSL10SD0 |
| 3DP Cervical Interbody System | 1 | Genesys Orthopedics Systems LLC | ODP OVE | M719GAC3D06SC0 |
| 3DP Cervical Interbody System | 1 | Genesys Orthopedics Systems LLC | ODP OVE | M719GAC3D08LC0 |
| 3DP Cervical Interbody System | 1 | Genesys Orthopedics Systems LLC | ODP OVE | M719GAC3D09LP0 |