Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K213359
SeaSpine WaveForm, C Interbody System · SeaSpine Orthopedics Corporation · decided 2021-12-09 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| 3D Printed Interbody Systems | AC4-164127 | Seaspine Orthopedics Corporation | ODP OVE | 10889981280956 |
| 3D Printed Interbody Systems | AC4-143127 | Seaspine Orthopedics Corporation | ODP OVE | 10889981280888 |
| 3D Printed Interbody Systems | AC4-185107 | Seaspine Orthopedics Corporation | ODP OVE | 10889981281007 |
| 3D Printed Interbody Systems | AC4-164117 | Seaspine Orthopedics Corporation | ODP OVE | 10889981280949 |
| 3D Printed Interbody Systems | AC4-164107 | Seaspine Orthopedics Corporation | ODP OVE | 10889981280932 |
| 3D Printed Interbody Systems | AC4-143087 | Seaspine Orthopedics Corporation | ODP OVE | 10889981280840 |
| 3D Printed Interbody Systems | AC4-164067 | Seaspine Orthopedics Corporation | ODP OVE | 10889981280895 |
| 3D Printed Interbody Systems | AC4-143077 | Seaspine Orthopedics Corporation | ODP OVE | 10889981280833 |
| 3D Printed Interbody Systems | AC4-164077 | Seaspine Orthopedics Corporation | ODP OVE | 10889981280901 |
| 3D Printed Interbody Systems | AC4-185097 | Seaspine Orthopedics Corporation | ODP OVE | 10889981280994 |
| 3D Printed Interbody Systems | AC4-143117 | Seaspine Orthopedics Corporation | ODP OVE | 10889981280871 |
| 3D Printed Interbody Systems | AC4-185077 | Seaspine Orthopedics Corporation | ODP OVE | 10889981280970 |
| 3D Printed Interbody Systems | AC4-185067 | Seaspine Orthopedics Corporation | ODP OVE | 10889981280963 |
| 3D Printed Interbody Systems | AC4-164097 | Seaspine Orthopedics Corporation | ODP OVE | 10889981280925 |
| 3D Printed Interbody Systems | AC4-164087 | Seaspine Orthopedics Corporation | ODP OVE | 10889981280918 |
| 3D Printed Interbody Systems | AC4-185117 | Seaspine Orthopedics Corporation | ODP OVE | 10889981281014 |
| 3D Printed Interbody Systems | AC4-185087 | Seaspine Orthopedics Corporation | ODP OVE | 10889981280987 |
| 3D Printed Interbody Systems | AC4-143107 | Seaspine Orthopedics Corporation | ODP OVE | 10889981280864 |
| 3D Printed Interbody Systems | AC4-143097 | Seaspine Orthopedics Corporation | ODP OVE | 10889981280857 |
| 3D Printed Interbody Systems | AC4-185127 | Seaspine Orthopedics Corporation | ODP OVE | 10889981281021 |