Company · US
Cutting Edge Spine, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2025. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 12, 2025 | K250605 | EVOL® ha Hyper C Cervical Interbody Fusion System Cutting Edge Spine, LLC | ODP |
| Apr 5, 2023 | K230689 | T-FIX 3DSI Joint Fusion System Cutting Edge Spine, LLC | OUR |
| Jun 24, 2022 | K214123 | T-FIX® 3DSI Joint Fusion System Cutting Edge Spine, LLC | OUR |
| May 13, 2020 | K200991 | EVOL Spinal Interbody System Cutting Edge Spine, LLC | MAX |
| Apr 2, 2020 | K200552 | EVOS Lumbar Interbody System Cutting Edge Spine, LLC | MAX |
| Jan 6, 2020 | K192497 | EVOL ha - D Lateral Interbody Fusion System Cutting Edge Spine, LLC | MAX |
| Aug 12, 2019 | K190025 | EVOL® -SI Joint Fusion System Cutting Edge Spine, LLC | OUR |
| Jun 25, 2018 | K180674 | EVOL® ha-C Cervical Interbody Fusion System Cutting Edge Spine, LLC | ODP |
| May 4, 2018 | K180891 | EVOL Spinal Interbody System, EVOS Lumbar Interbody System Cutting Edge Spine, LLC | MAX |
| Jul 13, 2015 | K150321 | EVOS Lumbar Interbody System Cutting Edge Spine, LLC | MAX |
| Apr 28, 2011 | K102957 | CUTTING EDGE SPINE INTERBODY FUSION DEVICE Cutting Edge Spine, LLC | MAX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||