Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K213420
WaveForm L System, WaveForm TO System, WaveForm TA System · SeaSpine Orthopedics Corporation · decided 2022-05-04 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| WaveForm TO | WO4-128105 | Seaspine Orthopedics Corporation | MAX PHM | 10889981288556 |
| WaveForm TO | WO4-928124 | Seaspine Orthopedics Corporation | MAX PHM | 10889981286637 |
| 3D Printed Interbody Systems | WL4-184000 | Seaspine Orthopedics Corporation | MAX PHM | 10889981301439 |
| WaveForm TO | WO4-924104 | Seaspine Orthopedics Corporation | MAX PHM | 10889981286323 |
| WaveForm TO | WO4-132165 | Seaspine Orthopedics Corporation | MAX PHM | 10889981288952 |
| WaveForm TO | WO4-924135 | Seaspine Orthopedics Corporation | MAX PHM | 10889981286422 |
| 3D Printed Interbody Systems | WL4-166015 | Seaspine Orthopedics Corporation | MAX PHM | 10889981306298 |
| WaveForm TO | WO4-132121 | Seaspine Orthopedics Corporation | MAX PHM | 10889981288815 |
| WaveForm TO | WO4-928104 | Seaspine Orthopedics Corporation | MAX PHM | 10889981286576 |
| 3D Printed Interbody Systems | WL4-264015 | Seaspine Orthopedics Corporation | MAX PHM | 10889981306380 |
| 3D Printed Interbody Systems | WL4-264500 | Seaspine Orthopedics Corporation | MAX PHM | 10889981306397 |
| 3D Printed Interbody Systems | WL4-125000 | Seaspine Orthopedics Corporation | MAX PHM | 10889981301286 |
| WaveForm TO | WO4-128135 | Seaspine Orthopedics Corporation | MAX PHM | 10889981288648 |
| 3D Printed Interbody Systems | WL4-205000 | Seaspine Orthopedics Corporation | MAX PHM | 10889981301576 |
| WaveForm TO | WO4-128111 | Seaspine Orthopedics Corporation | MAX PHM | 10889981288563 |
| 3D Printed Interbody Systems | WL4-106015 | Seaspine Orthopedics Corporation | MAX PHM | 10889981301224 |
| WaveForm TO | WO4-132144 | Seaspine Orthopedics Corporation | MAX PHM | 10889981288884 |
| 3D Printed Interbody Systems | WL4-245000 | Seaspine Orthopedics Corporation | MAX PHM | 10889981306335 |
| 3D Printed Interbody Systems | WL4-144010 | Seaspine Orthopedics Corporation | MAX PHM | 10889981306137 |
| 3D Printed Interbody Systems | WL4-285510 | Seaspine Orthopedics Corporation | MAX PHM | 10889981301903 |
| 3D Printed Interbody Systems | WL4-185010 | Seaspine Orthopedics Corporation | MAX PHM | 10889981301484 |
| WaveForm TO | WO4-928134 | Seaspine Orthopedics Corporation | MAX PHM | 10889981286668 |
| WaveForm TO | WO4-928135 | Seaspine Orthopedics Corporation | MAX PHM | 10889981286675 |
| 3D Printed Interbody Systems | WL4-265000 | Seaspine Orthopedics Corporation | MAX PHM | 10889981306427 |
| 3D Printed Interbody Systems | WL4-204000 | Seaspine Orthopedics Corporation | MAX PHM | 10889981301514 |