Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K162715
SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene · SeaSpine Orthopedics Corporation · decided 2016-10-28 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| SeaSpine Spacer System - Hollywood NanoMetalene | 34-5110-S | Seaspine Orthopedics Corporation | MAX MQP | 00889981034675 |
| SeaSpine Spacer System - Ventura NanoMetalene | 33-6910-S | Seaspine Orthopedics Corporation | MAX ODP | 00889981050040 |
| SeaSpine Spacer System - Ventura NanoMetalene | 33-6307-S | Seaspine Orthopedics Corporation | MAX ODP | 00889981049778 |
| Cambria NanoMetalene | 39-2808-S | Seaspine Orthopedics Corporation | MAX ODP | 00889981065013 |
| SeaSpine Spacer System - Ventura NanoMetalene | 33-6912-S | Seaspine Orthopedics Corporation | MAX ODP | 00889981050064 |
| SeaSpine Spacer System - Ventura NanoMetalene | 33-6213-S | Seaspine Orthopedics Corporation | MAX ODP | 00889981049716 |
| SeaSpine Spacer System - Hollywood NanoMetalene | 34-5116-S | Seaspine Orthopedics Corporation | MAX MQP | 00889981034736 |
| Cambria NanoMetalene | 39-2812-S | Seaspine Orthopedics Corporation | MAX ODP | 00889981065051 |
| SeaSpine Spacer System - Hollywood VI NanoMetalene | 34-8111-S | Seaspine Orthopedics Corporation | MAX ODP | 00889981034804 |
| SeaSpine Spacer System - Hollywood VI NanoMetalene | 34-9117-S | Seaspine Orthopedics Corporation | MAX ODP | 00889981064672 |
| SeaSpine Spacer System - Hollywood VI NanoMetalene | 34-9111-S | Seaspine Orthopedics Corporation | MAX ODP | 00889981064610 |
| SeaSpine Spacer System - Hollywood VI NanoMetalene | 34-9113-S | Seaspine Orthopedics Corporation | MAX ODP | 00889981064634 |
| SeaSpine Spacer System - Ventura NanoMetalene | 33-6313-S | Seaspine Orthopedics Corporation | MAX ODP | 00889981049839 |
| SeaSpine Spacer System - Ventura NanoMetalene | 33-6314-S | Seaspine Orthopedics Corporation | MAX ODP | 00889981049846 |
| SeaSpine Spacer System - Hollywood NanoMetalene | 34-5107-S | Seaspine Orthopedics Corporation | MAX MQP | 00889981034644 |
| SeaSpine Spacer System - Hollywood VI NanoMetalene | 34-8108-S | Seaspine Orthopedics Corporation | MAX ODP | 00889981034774 |
| Cambria NanoMetalene | 39-2811-S | Seaspine Orthopedics Corporation | MAX ODP | 00889981065044 |
| SeaSpine Spacer System - Ventura NanoMetalene | 33-6315-S | Seaspine Orthopedics Corporation | MAX ODP | 00889981049853 |
| Cambria NanoMetalene | 39-2410-S | Seaspine Orthopedics Corporation | MAX ODP | 00889981064887 |
| Cambria NanoMetalene | 39-2406-S | Seaspine Orthopedics Corporation | MAX ODP | 00889981064849 |
| SeaSpine Spacer System - Ventura NanoMetalene | 33-6211-S | Seaspine Orthopedics Corporation | MAX ODP | 00889981049693 |
| Cambria NanoMetalene | 39-2605-S | Seaspine Orthopedics Corporation | MAX ODP | 00889981064900 |
| SeaSpine Spacer System - Ventura NanoMetalene | 33-6210-S | Seaspine Orthopedics Corporation | MAX ODP | 00889981049686 |
| Cambria NanoMetalene | 39-2809-S | Seaspine Orthopedics Corporation | MAX ODP | 00889981065020 |
| Cambria NanoMetalene | 39-2609-S | Seaspine Orthopedics Corporation | MAX ODP | 00889981064948 |