K232432
- 510(k) number
- K232432
- Device name
- E3D-A Interbody System
- Applicant
- Evolution Spine TX · US
- Product code
- OVD — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2024-01-30
- Date received
- 2023-08-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K232432.pdf
Official FDA record: K232432
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.