Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K102323
CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE · Theken Spine, LLC · decided 2010-12-16 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Complete Cervical | 27-12-3514 | Seaspine Orthopedics Corporation | OVE | 10889981040741 |
| Complete Cervical | 27-14-4013 | Seaspine Orthopedics Corporation | OVE | 10889981041083 |
| Complete Cervical | 27-14-3512 | Seaspine Orthopedics Corporation | OVE | 10889981041007 |
| Complete Cervical | 27-10-1612 | Seaspine Orthopedics Corporation | OVE | 10889981040482 |
| Complete Cervical | 27-13-3511 | Seaspine Orthopedics Corporation | OVE | 10889981040857 |
| Complete Cervical | 27-12-4017 | Seaspine Orthopedics Corporation | OVE | 10889981040826 |
| Complete Cervical | 27-12-3511 | Seaspine Orthopedics Corporation | OVE | 10889981040710 |
| Complete Cervical | 27-10-1607 | Seaspine Orthopedics Corporation | OVE | 10889981040437 |
| Complete Cervical | 27-14-3518 | Seaspine Orthopedics Corporation | OVE | 10889981041069 |
| Complete Cervical | 27-14-3513 | Seaspine Orthopedics Corporation | OVE | 10889981041014 |
| Complete Cervical | 27-12-3517 | Seaspine Orthopedics Corporation | OVE | 10889981040772 |
| Complete Cervical | 27-12-3513 | Seaspine Orthopedics Corporation | OVE | 10889981040734 |
| Complete Cervical | 27-14-3511 | Seaspine Orthopedics Corporation | OVE | 10889981040994 |
| Complete Cervical | 27-11-3518 | Seaspine Orthopedics Corporation | OVE | 10889981040642 |
| Complete Cervical | 27-13-3513 | Seaspine Orthopedics Corporation | OVE | 10889981040871 |
| Complete Cervical | 27-12-3516 | Seaspine Orthopedics Corporation | OVE | 10889981040765 |
| Complete Cervical | 27-13-3512 | Seaspine Orthopedics Corporation | OVE | 10889981040864 |
| Complete Cervical | 27-14-4019 | Seaspine Orthopedics Corporation | OVE | 10889981041113 |
| Complete Cervical | 27-13-4017 | Seaspine Orthopedics Corporation | OVE | 10889981040963 |
| Complete Cervical | 27-12-4011 | Seaspine Orthopedics Corporation | OVE | 10889981040796 |
| Complete Cervical | 27-12-3518 | Seaspine Orthopedics Corporation | OVE | 10889981040789 |
| Complete Cervical | 27-12-3510 | Seaspine Orthopedics Corporation | OVE | 10889981040703 |
| Complete Cervical | 27-10-1609 | Seaspine Orthopedics Corporation | OVE | 10889981040451 |
| Complete Cervical | 27-12-4015 | Seaspine Orthopedics Corporation | OVE | 10889981040819 |
| Complete Cervical | 27-12-4019 | Seaspine Orthopedics Corporation | OVE | 10889981040833 |