K260038
- 510(k) number
- K260038
- Device name
- E3D-C Interbody System
- Applicant
- Evolution Spine TX · US
- Product code
- OVE — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2026-02-04
- Date received
- 2026-01-06
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K260038.pdf
Official FDA record: K260038
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.