K261352
- 510(k) number
- K261352
- Device name
- 2D Hip Planning Software
- Applicant
- One Ortho FR
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2026-06-08
- Date received
- 2026-04-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K261352.pdf
Official FDA record: K261352
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.