Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K150321
EVOS Lumbar Interbody System · Cutting Edge Spine, LLC · decided 2015-07-13 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| EVOS Lumbar Interbody System | 4716-012 | Cutting Edge Spine, LLC | MAX | 00841193119212 |
| EVOS Lumbar Interbody System | 4615-010 | Cutting Edge Spine, LLC | MAX | 00841193118802 |
| EVOS Lumbar Interbody System | 4319-010 | Cutting Edge Spine, LLC | MAX | 00841193117423 |
| EVOS Lumbar Interbody System | 4230-013 | Cutting Edge Spine, LLC | MAX | 00841193115733 |
| EVOS Lumbar Interbody System | 4216-016 | Cutting Edge Spine, LLC | MAX | 00841193114767 |
| EVOS Lumbar Interbody System | 4206-016 | Cutting Edge Spine, LLC | MAX | 00841193113920 |
| EVOS Lumbar Interbody System | 4202-013 | Cutting Edge Spine, LLC | MAX | 00841193113456 |
| EVOS Lumbar Interbody System | 4119-013 | Cutting Edge Spine, LLC | MAX | 00841193109831 |
| EVOS Lumbar Interbody System | 4110-012 | Cutting Edge Spine, LLC | MAX | 00841193108957 |
| EVOS Lumbar Interbody System | 4026-014 | Cutting Edge Spine, LLC | MAX | 00841193107400 |
| EVOS Lumbar Interbody System | 4015-015 | Cutting Edge Spine, LLC | MAX | 00841193106496 |
| EVOS Lumbar Interbody System | 4011-007 | Cutting Edge Spine, LLC | MAX | 00841193106335 |
| EVOS Lumbar Interbody System | 4011-006 | Cutting Edge Spine, LLC | MAX | 00841193106328 |
| EVOS Lumbar Interbody System | 4057-010 | Cutting Edge Spine, LLC | MAX | 00841193103891 |
| EVOS Lumbar Interbody System | 4231-009 | Cutting Edge Spine, LLC | MAX | 00841193101767 |
| EVOS Lumbar Interbody System | 4013-016 | Cutting Edge Spine, LLC | MAX | 00841193100791 |
| EVOS Lumbar Interbody System | 4212-011 | Cutting Edge Spine, LLC | MAX | 00841193100647 |
| EVOS Lumbar Interbody System | 4615-014 | Cutting Edge Spine, LLC | MAX | 00841193118840 |
| EVOS Lumbar Interbody System | 4406-013 | Cutting Edge Spine, LLC | MAX | 00841193117898 |
| EVOS Lumbar Interbody System | 4406-011 | Cutting Edge Spine, LLC | MAX | 00841193117874 |
| EVOS Lumbar Interbody System | 4311-014 | Cutting Edge Spine, LLC | MAX | 00841193116822 |
| EVOS Lumbar Interbody System | 4226-012 | Cutting Edge Spine, LLC | MAX | 00841193115450 |
| EVOS Lumbar Interbody System | 4482-012 | Cutting Edge Spine, LLC | MAX | 00841193112152 |
| EVOS Lumbar Interbody System | 4277-012 | Cutting Edge Spine, LLC | MAX | 00841193111179 |
| EVOS Lumbar Interbody System | 4026-010 | Cutting Edge Spine, LLC | MAX | 00841193107363 |