K232140
- 510(k) number
- K232140
- Device name
- OTS Hip
- Applicant
- Ortoma AB SE
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2024-03-11
- Date received
- 2023-07-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K232140.pdf
Official FDA record: K232140
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.