Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K181079
SeaSpine Regatta Lateral System · SeaSpine Orthopedics Corporation · decided 2018-07-18 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Regatta Lateral System | 36-381055-10 | Seaspine Orthopedics Corporation | MAX | 10889981162801 |
| Regatta Lateral System | 36-230845-10 | Seaspine Orthopedics Corporation | MAX | 10889981162108 |
| Regatta Lateral System | 36-181240-10 | Seaspine Orthopedics Corporation | MAX | 10889981158309 |
| Regatta | 36-181455-00 | Seaspine Orthopedics Corporation | MAX | 10889981158538 |
| Regatta Lateral System | 36-431055-10 | Seaspine Orthopedics Corporation | MAX | 10889981162948 |
| Regatta Lateral System | 36-231060-10 | Seaspine Orthopedics Corporation | MAX | 10889981158880 |
| Regatta Lateral System | 36-181050-15 | Seaspine Orthopedics Corporation | MAX | 10889981158224 |
| Regatta | 36-180855-00 | Seaspine Orthopedics Corporation | MAX | 10889981158101 |
| Regatta Lateral System | 36-181260-15 | Seaspine Orthopedics Corporation | MAX | 10889981158439 |
| Regatta Lateral System | 36-381455-15 | Seaspine Orthopedics Corporation | MAX | 10889981162870 |
| Regatta Lateral System | 36-181255-10 | Seaspine Orthopedics Corporation | MAX | 10889981158392 |
| Regatta Lateral System | 36-431055-15 | Seaspine Orthopedics Corporation | MAX | 10889981162955 |
| Regatta Lateral System | 36-181250-00 | Seaspine Orthopedics Corporation | MAX | 10889981158354 |
| Regatta Lateral System | 36-181440-00 | Seaspine Orthopedics Corporation | MAX | 10889981158446 |
| Regatta Lateral System | 36-181445-15 | Seaspine Orthopedics Corporation | MAX | 10889981158491 |
| Specials | SR-1229 | Seaspine Orthopedics Corporation | MAX | 10889981326098 |
| Regatta | 36-181645-00 | Seaspine Orthopedics Corporation | MAX | 10889981158620 |
| Regatta Lateral System | 36-231445-15 | Seaspine Orthopedics Corporation | MAX | 10889981159092 |
| Regatta Lateral System | 36-181445-10 | Seaspine Orthopedics Corporation | MAX | 10889981158484 |
| Regatta Lateral System | 36-180845-10 | Seaspine Orthopedics Corporation | MAX | 10889981158071 |
| Regatta Lateral System | 36-431655-15 | Seaspine Orthopedics Corporation | MAX | 10889981163044 |
| Regatta Lateral System | 36-231260-15 | Seaspine Orthopedics Corporation | MAX | 10889981159030 |
| Regatta Lateral System | 36-231040-00 | Seaspine Orthopedics Corporation | MAX | 10889981158798 |
| Specials | SR-0886 | Seaspine Orthopedics Corporation | MAX | 10889981301095 |
| Regatta Lateral System | 36-231255-10 | Seaspine Orthopedics Corporation | MAX | 10889981158996 |