K243386
- 510(k) number
- K243386
- Device name
- Ventris Intervertebral Body Fusion Device
- Applicant
- Acuity Surgical Devices, LLC TX · US
- Product code
- OVD — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2025-04-22
- Date received
- 2024-10-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K243386.pdf
Official FDA record: K243386
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.