K241846
- 510(k) number
- K241846
- Device name
- E3D-C Interbody System
- Applicant
- Evolution Spine TX · US
- Product code
- OVE — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2024-08-12
- Date received
- 2024-06-26
- 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: K241846.pdf
Official FDA record: K241846
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.