Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K180891
EVOL Spinal Interbody System, EVOS Lumbar Interbody System · Cutting Edge Spine, LLC · decided 2018-05-04 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| EVOL® Lumbar Interbody System | HLB04012 | Cutting Edge Spine, LLC | MAX | 00841193120751 |
| EVOL® Lumbar Interbody System | HLB04009 | Cutting Edge Spine, LLC | MAX | 00841193120744 |
| EVOL® Lumbar Interbody System | HLB04011 | Cutting Edge Spine, LLC | MAX | 00841193120720 |
| EVOL® Lumbar Interbody System | HLB04017 | Cutting Edge Spine, LLC | MAX | 00841193120805 |
| EVOL® Lumbar Interbody System | HLB04014 | Cutting Edge Spine, LLC | MAX | 00841193120775 |
| EVOL® Lumbar Interbody System | HLB04016 | Cutting Edge Spine, LLC | MAX | 00841193120799 |
| EVOL® Lumbar Interbody System | HLB04015 | Cutting Edge Spine, LLC | MAX | 00841193120782 |
| EVOL® Lumbar Interbody System | HLB04013 | Cutting Edge Spine, LLC | MAX | 00841193120768 |
| EVOL® Lumbar Interbody System | HLB04010 | Cutting Edge Spine, LLC | MAX | 00841193120737 |