K230352
- 510(k) number
- K230352
- Device name
- Tornier Humeral Nail and Tornier Long Humeral Nail
- Applicant
- Tornier, Inc. MN · US
- Product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Decision date
- 2023-10-31
- Date received
- 2023-02-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K230352.pdf
Official FDA record: K230352
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.