K243865
- 510(k) number
- K243865
- Device name
- AERO MIS Facet Fusion System
- Applicant
- Aurora Spine CA · US
- Product code
- MRW — System, Facet Screw Spinal Device
- Decision date
- 2025-03-24
- Date received
- 2024-12-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K243865.pdf
Official FDA record: K243865
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.