K260321
- 510(k) number
- K260321
- Device name
- HipGuide (V 1.0.0.0)
- Applicant
- Orthopedic Driven Imaging, LLC FL · US
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2026-05-08
- Date received
- 2026-01-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K260321.pdf
Official FDA record: K260321
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.