K253805
- 510(k) number
- K253805
- Device name
- Knee+
- Applicant
- Pixee Medical S.A.S. FR
- Product code
- SBF — Orthopedic Augmented Reality
- Decision date
- 2026-04-24
- Date received
- 2025-11-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K253805.pdf
Official FDA record: K253805
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.