K250316
- 510(k) number
- K250316
- Device name
- Meduloc Intramedullary Fracture Fixation (IFF) System
- Applicant
- Meduloc, LLC CA · US
- Product code
- JDW — Pin, Fixation, Threaded
- Decision date
- 2025-10-29
- Date received
- 2025-02-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K250316.pdf
Official FDA record: K250316
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.