Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K142488
SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene · Seaspine, Inc. · decided 2014-12-18 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Cambria™ NanoMetalene® | 93-9855 | Seaspine Orthopedics Corporation | ODP | 10889981094003 |
| SeaSpine Spacer System - Ventura™ NanoMetalene® | 93-3884 | Seaspine Orthopedics Corporation | MAX ODP | 10889981050610 |
| Cambria™ NanoMetalene® | 93-9852 | Seaspine Orthopedics Corporation | ODP | 10889981093990 |
| Cambria™ NanoMetalene® | 39-2407 | Seaspine Orthopedics Corporation | ODP | 10889981064853 |
| SeaSpine Spacer System - Ventura™ NanoMetalene® | 93-3883 | Seaspine Orthopedics Corporation | MAX ODP | 10889981050603 |
| SeaSpine Spacer System - Ventura™ NanoMetalene® | 93-3876 | Seaspine Orthopedics Corporation | MAX ODP | 10889981050535 |
| SeaSpine Spacer System - Hollywood NanoMetalene | 34-9110 | Seaspine Orthopedics Corporation | MAX ODP | 10889981064600 |
| Cambria™ NanoMetalene® | 93-9858 | Seaspine Orthopedics Corporation | ODP | 10889981094034 |
| Cambria™ NanoMetalene® | 39-2608 | Seaspine Orthopedics Corporation | ODP | 10889981064938 |
| Cambria™ NanoMetalene® | 39-2805 | Seaspine Orthopedics Corporation | ODP | 10889981064983 |
| SeaSpine Spacer System - Ventura™ NanoMetalene® | 93-3881 | Seaspine Orthopedics Corporation | MAX ODP | 10889981050580 |
| SeaSpine Spacer System - Ventura™ NanoMetalene® | 33-6916 | Seaspine Orthopedics Corporation | MAX ODP | 10889981050108 |
| Cambria™ NanoMetalene® | 93-9861 | Seaspine Orthopedics Corporation | ODP | 10889981094065 |
| SeaSpine Spacer System - Ventura™ NanoMetalene® | 93-3873 | Seaspine Orthopedics Corporation | MAX ODP | 10889981050504 |
| SeaSpine Spacer System - Ventura™ NanoMetalene® | 33-6317 | Seaspine Orthopedics Corporation | MAX ODP | 10889981049874 |
| Cambria™ NanoMetalene® | 39-2808 | Seaspine Orthopedics Corporation | ODP | 10889981065010 |
| SeaSpine Spacer System - Ventura™ NanoMetalene® | 33-6808 | Seaspine Orthopedics Corporation | MAX ODP | 10889981049904 |
| SeaSpine Spacer System - Ventura™ NanoMetalene® | 33-6909 | Seaspine Orthopedics Corporation | MAX ODP | 10889981050030 |
| SeaSpine Spacer System - Ventura™ NanoMetalene® | 93-3823 | Seaspine Orthopedics Corporation | MAX ODP | 10889981050245 |
| SeaSpine Spacer System - Ventura™ NanoMetalene® | 93-3801 | Seaspine Orthopedics Corporation | MAX ODP | 10889981050146 |
| Cambria™ NanoMetalene® | 39-2612 | Seaspine Orthopedics Corporation | ODP | 10889981064976 |
| SeaSpine Spacer System - Hollywood NanoMetalene | 93-4508 | Seaspine Orthopedics Corporation | MAX ODP | 10889981129644 |
| Cambria™ NanoMetalene® | 93-9857 | Seaspine Orthopedics Corporation | ODP | 10889981094027 |
| SeaSpine Spacer System - Ventura™ NanoMetalene® | 33-6817 | Seaspine Orthopedics Corporation | MAX ODP | 10889981049997 |
| SeaSpine Spacer System - Ventura™ NanoMetalene® | 33-6310 | Seaspine Orthopedics Corporation | MAX ODP | 10889981049805 |