K241487
- 510(k) number
- K241487
- Device name
- Interwedge® Standalone Lateral
- Applicant
- Foundation Surgical Group, Inc. AZ · US
- Product code
- OVD — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2024-10-02
- Date received
- 2024-05-24
- 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: K241487.pdf
Official FDA record: K241487
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.