K240623
- 510(k) number
- K240623
- Device name
- Omnia Medical TiBrid-SA System
- Applicant
- Omnia Medical, LLC WV · US
- Product code
- OVD — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2024-04-24
- Date received
- 2024-03-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K240623.pdf
Official FDA record: K240623
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.