Data / Medical devices / United States / Cutting Edge Spine
Cutting Edge Spine: FDA-registered device maker in Mineral Spgs, NC, United States, 9 510(k) clearances
Cutting Edge Spine is registered with the FDA (registration 3009129735) in Mineral Spgs, NC, United States. It lists 3 device types. The FDA files 9 510(k) clearances under its listings, the newest dated March 12, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009129735
- Address
- 6012 Waxhaw Highway, Mineral Spgs, NC, United States, 28108
- Owner or operator
- Cutting Edge Spine (10036880)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- September 8, 2015
- Registered through
- 2026
- Brand names listed
- EVOLha-LIF Interbody System, EVOL® Lumbar Interbody System, EVOL®SI Joint Fusion System, EVOL®ha-C Cervical Interbody System, EVOL®ha-D Lateral Interbody Fusion System, EVOL®ha-Hyper C Cervical Interbody System, EVOS Lumbar Interbody System, T-FIX3Dsi Joint Fusion System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Sacroiliac Joint Fixation | OUR | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 12, 2025 | K250605 | EVOL® ha Hyper C Cervical Interbody Fusion System | ODP | Substantially Equivalent | Cutting Edge Spine, LLC | accessdata.fda.gov |
| June 24, 2022 | K214123 | T-FIX® 3DSI Joint Fusion System | OUR | Substantially Equivalent | Cutting Edge Spine, LLC | accessdata.fda.gov |
| May 13, 2020 | K200991 | EVOL Spinal Interbody System | MAX | Substantially Equivalent | Cutting Edge Spine, LLC | accessdata.fda.gov |
| April 2, 2020 | K200552 | EVOS Lumbar Interbody System | MAX | Substantially Equivalent | Cutting Edge Spine, LLC | accessdata.fda.gov |
| January 6, 2020 | K192497 | EVOL ha - D Lateral Interbody Fusion System | MAX | Substantially Equivalent | Cutting Edge Spine, LLC | accessdata.fda.gov |
| August 12, 2019 | K190025 | EVOL® -SI Joint Fusion System | OUR | Substantially Equivalent | Cutting Edge Spine, LLC | accessdata.fda.gov |
| June 25, 2018 | K180674 | EVOL® ha-C Cervical Interbody Fusion System | ODP | Substantially Equivalent | Cutting Edge Spine, LLC | accessdata.fda.gov |
| May 4, 2018 | K180891 | EVOL Spinal Interbody System, EVOS Lumbar Interbody System | MAX | Substantially Equivalent | Cutting Edge Spine, LLC | accessdata.fda.gov |
| July 13, 2015 | K150321 | EVOS Lumbar Interbody System | MAX | Substantially Equivalent | Cutting Edge Spine, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Sacroiliac Joint Fixation
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
Updated March 12, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.