Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Cutting Edge Spine with 11 510(k) clearances. The most recent is a 510(k) clearance dated Mar 12, 2025: EVOL® ha – Hyper C Cervical Interbody Fusion System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 12, 2025 | EVOL® ha – Hyper C Cervical Interbody Fusion SystemK250605 · ODP | 510(k) clearances |
| Apr 5, 2023 | T-FIX™ 3DSI Joint Fusion SystemK230689 · OUR | 510(k) clearances |
| Jun 24, 2022 | T-FIX® 3DSI Joint Fusion SystemK214123 · OUR | 510(k) clearances |
| May 13, 2020 | EVOL Spinal Interbody SystemK200991 · MAX | 510(k) clearances |
| Apr 2, 2020 | EVOS Lumbar Interbody SystemK200552 · MAX | 510(k) clearances |
| Jan 6, 2020 | EVOL ha - D Lateral Interbody Fusion SystemK192497 · MAX | 510(k) clearances |
| Aug 12, 2019 | EVOL® -SI Joint Fusion SystemK190025 · OUR | 510(k) clearances |
| Jun 25, 2018 | EVOL® ha-C Cervical Interbody Fusion SystemK180674 · ODP | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
