K261809
- 510(k) number
- K261809
- Device name
- Interwedge® Standalone Lateral
- Applicant
- Foundation Surgical Group AZ · US
- Product code
- OVD — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2026-07-31
- Date received
- 2026-06-01
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K261809.pdf
Official FDA record: K261809
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.