K242806
- 510(k) number
- K242806
- Device name
- Medyssey Navigation System
- Applicant
- Medyssey Co, Ltd. KR
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-04-16
- Date received
- 2024-09-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K242806.pdf
Official FDA record: K242806
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.