K250086
- 510(k) number
- K250086
- Device name
- OTS Hip
- Applicant
- Ortoma AB SE
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-05-16
- Date received
- 2025-01-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K250086.pdf
Official FDA record: K250086
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.