K253291
- 510(k) number
- K253291
- Device name
- Excelsior System
- Applicant
- Blue Ocean Global FL · US
- Product code
- KTT — Appliance, Fixation, Nail/Blade/Plate Combination, M
- Decision date
- 2026-01-20
- Date received
- 2025-09-29
- 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: K253291.pdf
Official FDA record: K253291
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.