E3D-C Interbody System— 510(k) K260038
Substantially EquivalentEvolution Spine
FDA 510(k) clearance K260038 for E3D-C Interbody System, Substantially Equivalent on 2026-02-04. Applicant: Evolution Spine. Device class: 2.
Summary
Evolution Spine's E3D-C Interbody System is filed under product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical). The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel, and it came in as a Special 510(k).
Evolution Spine filed from Dallas, Texas. The decision came 29 calendar days after FDA received it (January 6 to February 4, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Evolution Spine
- Product code
- Product code OVE
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Dallas, TX, US
Recent devices under product code OVE
view allMore clearances from Evolution Spine
view allAdverse events under product code OVE
product code OVE- Injury
- 293
- Malfunction
- 710
- Total
- 1,003
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.