K240175
- 510(k) number
- K240175
- Device name
- Tigon Medical Fractures, Instability, and Reconstruction (FIRE)
- Applicant
- Tigon Medical MD · US
- Product code
- HWC — Screw, Fixation, Bone
- Decision date
- 2024-10-29
- Date received
- 2024-01-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K240175.pdf
Official FDA record: K240175
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.