K231649
- 510(k) number
- K231649
- Device name
- Intraosseous Fusion Device System
- Applicant
- Auxano Medical, LLC OH · US
- Product code
- HWC — Screw, Fixation, Bone
- Decision date
- 2023-09-29
- Date received
- 2023-06-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K231649.pdf
Official FDA record: K231649
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.