Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K222732
WaveForm A Interbody System · SeaSpine Orthopedics Corporation · decided 2022-11-07 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| WaveForm A | WA4-331010 | Seaspine Orthopedics Corporation | MAX OVD | 10889981304447 |
| WaveForm A | WA4-301410 | Seaspine Orthopedics Corporation | MAX OVD | 10889981304249 |
| WaveForm A | WA4-341615 | Seaspine Orthopedics Corporation | MAX OVD | 10889981304621 |
| 3D Printed Interbody System | WA4-131210 | Seaspine Orthopedics Corporation | MAX OVD | 10889981303617 |
| WaveForm A | WA4-331420 | Seaspine Orthopedics Corporation | MAX OVD | 10889981304492 |
| 3D Printed Interbody System | WA4-132025 | Seaspine Orthopedics Corporation | MAX OVD | 10889981303716 |
| 3D Printed Interbody System | WA4-141210 | Seaspine Orthopedics Corporation | MAX OVD | 10889981303730 |
| WaveForm A | WA4-311215 | Seaspine Orthopedics Corporation | MAX OVD | 10889981304348 |
| WaveForm A | WA4-302025 | Seaspine Orthopedics Corporation | MAX OVD | 10889981304317 |
| WaveForm A | WA4-311210 | Seaspine Orthopedics Corporation | MAX OVD | 10889981304331 |
| WaveForm A | WA4-331610 | Seaspine Orthopedics Corporation | MAX OVD | 10889981304508 |
| 3D Printed Interbody System | WA4-111615 | Seaspine Orthopedics Corporation | MAX OVD | 10889981303556 |
| 3D Printed Interbody System | WA4-101620 | Seaspine Orthopedics Corporation | MAX OVD | 10889981303457 |
| 3D Printed Interbody System | WA4-101420 | Seaspine Orthopedics Corporation | MAX OVD | 10889981303426 |
| 3D Printed Interbody System | WA4-131820 | Seaspine Orthopedics Corporation | MAX OVD | 10889981303693 |
| WaveForm A | WA4-301825 | Seaspine Orthopedics Corporation | MAX OVD | 10889981304300 |
| 3D Printed Interbody System | WA4-101010 | Seaspine Orthopedics Corporation | MAX OVD | 10889981303372 |
| 3D Printed Interbody System | WA4-131415 | Seaspine Orthopedics Corporation | MAX OVD | 10889981303648 |
| WaveForm A | WA4-311415 | Seaspine Orthopedics Corporation | MAX OVD | 10889981304362 |
| 3D Printed Interbody System | WA4-131620 | Seaspine Orthopedics Corporation | MAX OVD | 10889981303686 |
| 3D Printed Interbody System | WA4-141615 | Seaspine Orthopedics Corporation | MAX OVD | 10889981303785 |
| 3D Printed Interbody System | WA4-141410 | Seaspine Orthopedics Corporation | MAX OVD | 10889981303754 |
| WaveForm A | WA4-331620 | Seaspine Orthopedics Corporation | MAX OVD | 10889981304522 |
| 3D Printed Interbody System | WA4-101415 | Seaspine Orthopedics Corporation | MAX OVD | 10889981303419 |
| WaveForm A | WA4-341010 | Seaspine Orthopedics Corporation | MAX OVD | 10889981304560 |