K231739
- 510(k) number
- K231739
- Device name
- Cervical Spine Truss System (CSTS)
- Applicant
- 4Web Medical, Inc. TX · US
- Product code
- OVE — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2023-09-25
- Date received
- 2023-06-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K231739.pdf
Official FDA record: K231739
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.