K240368
- 510(k) number
- K240368
- Device name
- E3D-A Interbody System
- Applicant
- Evolution Spine TX · US
- Product code
- OVD — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2024-05-15
- Date received
- 2024-02-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K240368.pdf
Official FDA record: K240368
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.