K262094
- 510(k) number
- K262094
- Device name
- E3D-C Interbody System
- Applicant
- Evolution Spine TX · US
- Product code
- OVE — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2026-07-22
- Date received
- 2026-06-22
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K262094.pdf
Official FDA record: K262094
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.