Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K233694
Meridian Interbody System; WaveForm A Interbody System · SeaSpine Orthopedics Corporation · decided 2024-01-12 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Meridian® WaveForm® A | WA4-401010 | Seaspine Orthopedics Corporation | MAX OVD | 10889981326265 |
| WaveForm® A | WA4-401415 | Seaspine Orthopedics Corporation | MAX OVD | 10889981326524 |
| Meridian® WaveForm® A | WA4-401415 | Seaspine Orthopedics Corporation | MAX OVD | 10889981326302 |
| WaveForm® A | WA4-411410 | Seaspine Orthopedics Corporation | MAX OVD | 10889981326586 |
| WaveForm® A | WA4-431610 | Seaspine Orthopedics Corporation | MAX OVD | 10889981326678 |
| Meridian | RA1-250412 | Seaspine Orthopedics Corporation | MAX OVD | 10889981310363 |
| Meridian® WaveForm® A | WA4-431415 | Seaspine Orthopedics Corporation | MAX OVD | 10889981326449 |
| Meridian | RA1-250420 | Seaspine Orthopedics Corporation | MAX OVD | 10889981310400 |
| WaveForm® A | WA4-411415 | Seaspine Orthopedics Corporation | MAX OVD | 10889981326593 |
| Meridian® WaveForm® A | WA4-401210 | Seaspine Orthopedics Corporation | MAX OVD | 10889981326272 |
| General | RA3-009033 | Seaspine Orthopedics Corporation | MAX OVD | 10889981325091 |
| WaveForm® A | WA4-431210 | Seaspine Orthopedics Corporation | MAX OVD | 10889981326630 |
| WaveForm® A | WA4-401010 | Seaspine Orthopedics Corporation | MAX OVD | 10889981326487 |
| Meridian® WaveForm® A | WA4-431010 | Seaspine Orthopedics Corporation | MAX OVD | 10889981326401 |
| Meridian | RA1-504330 | Seaspine Orthopedics Corporation | MAX OVD | 10889981310448 |
| Meridian® WaveForm® A | WA4-431215 | Seaspine Orthopedics Corporation | MAX OVD | 10889981326425 |
| Meridian® WaveForm® A | WA4-431410 | Seaspine Orthopedics Corporation | MAX OVD | 10889981326432 |
| Meridian | RA1-250416 | Seaspine Orthopedics Corporation | MAX OVD | 10889981310387 |
| WaveForm® A | WA4-431410 | Seaspine Orthopedics Corporation | MAX OVD | 10889981326654 |
| WaveForm® A | WA4-411210 | Seaspine Orthopedics Corporation | MAX OVD | 10889981326562 |
| Meridian® WaveForm® A | WA4-411410 | Seaspine Orthopedics Corporation | MAX OVD | 10889981326364 |
| Meridian® WaveForm® A | WA4-401215 | Seaspine Orthopedics Corporation | MAX OVD | 10889981326289 |
| WaveForm® A | WA4-411215 | Seaspine Orthopedics Corporation | MAX OVD | 10889981326579 |
| WaveForm® A | WA4-431415 | Seaspine Orthopedics Corporation | MAX OVD | 10889981326661 |
| Meridian® WaveForm® A | WA4-411610 | Seaspine Orthopedics Corporation | MAX OVD | 10889981326388 |