K250628
- 510(k) number
- K250628
- Device name
- DynaNail TTC Fusion System
- Applicant
- MedShape, Inc. GA · US
- Product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Decision date
- 2025-09-12
- Date received
- 2025-03-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K250628.pdf
Official FDA record: K250628
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.