K251735
- 510(k) number
- K251735
- Device name
- Stabilis SA Cervical Stand-Alone System (Various PNs)
- Applicant
- Acuity Surgical Devices, LLC TX · US
- Product code
- OVE — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2025-07-30
- Date received
- 2025-06-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.8 MB · U.S. public domain
Also available from FDA: K251735.pdf
Official FDA record: K251735
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.