K233134
- 510(k) number
- K233134
- Device name
- I.T.S. INS Proximal Femur Nail
- Applicant
- I.T.S. GmbH AT
- Product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Decision date
- 2024-02-12
- Date received
- 2023-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K233134.pdf
Official FDA record: K233134
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.