K261852
- 510(k) number
- K261852
- Device name
- OTS Hip
- Applicant
- Ortoma AB SE
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2026-07-01
- Date received
- 2026-06-03
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K261852.pdf
Official FDA record: K261852
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.