Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K161081
SeaSpine Shoreline ACS - Anterior Cervical Standalone System · SeaSpine Orthopedics Corporation · decided 2016-09-14 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Shoreline ACS | 86-0509 | Seaspine Orthopedics Corporation | OVE | 10889981127510 |
| Shoreline ACS | 85-3314 | Seaspine Orthopedics Corporation | OVE | 10889981125295 |
| Shoreline ACS | 85-0507 | Seaspine Orthopedics Corporation | OVE | 10889981124175 |
| Shoreline ACS | 85-1708 | Seaspine Orthopedics Corporation | OVE | 10889981124892 |
| Shoreline ACS | 86-0415 | Seaspine Orthopedics Corporation | OVE | 10889981127381 |
| Shoreline ACS | 86-0307 | Seaspine Orthopedics Corporation | OVE | 10889981127312 |
| Shoreline ACS | 85-3020 | Seaspine Orthopedics Corporation | OVE | 10889981137410 |
| Shoreline ACS | 86-0309 | Seaspine Orthopedics Corporation | OVE | 10889981127336 |
| Shoreline ACS | 85-1010 | Seaspine Orthopedics Corporation | OVE | 10889981124601 |
| Shoreline ACS | 86-1007 | Seaspine Orthopedics Corporation | OVE | 10889981127435 |
| Shoreline ACS | 86-0111 | Seaspine Orthopedics Corporation | OVE | 10889981127190 |
| Shoreline ACS | 85-3312 | Seaspine Orthopedics Corporation | OVE | 10889981125288 |
| Shoreline ACS | 85-1105 | Seaspine Orthopedics Corporation | OVE | 10889981124632 |
| Shoreline ACS | 85-0307 | Seaspine Orthopedics Corporation | OVE | 10889981124090 |
| Shoreline ACS | 86-9911 | Seaspine Orthopedics Corporation | OVE | 10889981127701 |
| Shoreline ACS | 86-0507 | Seaspine Orthopedics Corporation | OVE | 10889981127497 |
| Shoreline ACS | 85-2109 | Seaspine Orthopedics Corporation | OVE | 10889981125103 |
| Shoreline ACS | 85-3010 | Seaspine Orthopedics Corporation | OVE | 10889981125141 |
| Shoreline ACS | 85-2107 | Seaspine Orthopedics Corporation | OVE | 10889981125080 |
| Shoreline ACS | 85-0910 | Seaspine Orthopedics Corporation | OVE | 10889981124526 |
| Shoreline ACS | 85-0210 | Seaspine Orthopedics Corporation | OVE | 10889981124052 |
| Shoreline ACS | 85-1712 | Seaspine Orthopedics Corporation | OVE | 10889981124939 |
| Shoreline ACS | 86-1510 | Seaspine Orthopedics Corporation | OVE | 10889981130404 |
| Shoreline ACS | 86-1308 | Seaspine Orthopedics Corporation | OVE | 10889981130244 |
| Shoreline ACS | 86-0910 | Seaspine Orthopedics Corporation | OVE | 10889981127626 |