K253507
- 510(k) number
- K253507
- Device name
- Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee
- Applicant
- Orthalign, Inc. CA · US
- Product code
- ONN — Intraoperative Orthopedic Joint Assessment Aid
- Decision date
- 2026-06-02
- Date received
- 2025-11-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K253507.pdf
Official FDA record: K253507
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.