Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K162103
Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye) · Choicespine, LP · decided 2016-11-23 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Octane Straight IR | PT23-32116 | Choice Spine, LP | MAX MPQ | 00840996163767 |
| Octane Straight IR | PT23-36136 | Choice Spine, LP | MAX MPQ | 00840996163736 |
| Octane Straight IR | PT23-32136 | Choice Spine, LP | MAX MPQ | 00840996163781 |
| Octane Straight IR | PT23-32146 | Choice Spine, LP | MAX MPQ | 00840996163798 |
| Octane Straight IR | PT23-32126 | Choice Spine, LP | MAX MPQ | 00840996163774 |
| CHOICE SPINE LUMBAR SPACER SYSTEM | P070-CUP01 | Choice Spine, LP | MAX MQP | 00840996170628 |
| CHOICE SPINE LUMBAR SPACER SYSTEM | P070-CUP02 | Choice Spine, LP | MAX MQP | 00840996170635 |
| CHOICE SPINE LUMBAR SPACER SYSTEM | P070-CUP05 | Choice Spine, LP | MAX MQP | 00840996170666 |
| HARRIER Choice Spine Intervertebral Body Device | J070-0045 | Choice Spine, LP | LXH | 00840996157308 |
| Octane Straight IR | PT23-36116 | Choice Spine, LP | MAX MPQ | 00840996163712 |
| CHOICE SPINE LUMBAR SPACER SYSTEM | P070-CUP03 | Choice Spine, LP | MAX MQP | 00840996170642 |
| Octane Straight IR | PT23-36126 | Choice Spine, LP | MAX MPQ | 00840996163729 |
| Octane Straight IR | PT23-36156 | Choice Spine, LP | MAX MPQ | 00840996163750 |
| HARRIER Choice Spine Intervertebral Body Device | J070-0046 | Choice Spine, LP | LXH | 00840996157315 |
| Octane Straight IR | PT23-36146 | Choice Spine, LP | MAX MPQ | 00840996163743 |
| Octane Straight IR | PT23-32156 | Choice Spine, LP | MAX MPQ | 00840996163804 |
| CHOICE SPINE LUMBAR SPACER SYSTEM | P070-CUP04 | Choice Spine, LP | MAX MQP | 00840996170659 |