K253611
- 510(k) number
- K253611
- Device name
- Falco Fusion System
- Applicant
- Mcnicoll Surgical, Inc. CA
- Product code
- OUR — Sacroiliac Joint Fixation
- Decision date
- 2026-01-29
- Date received
- 2025-11-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253611.pdf
Official FDA record: K253611
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.